-
- Lat Carto Mapping Biosense
- Biosense Webster Cables
- Them to Biosense Webster. Overview: At Biosense Webster, we have an ongoing commitment to patient safety and continuously monitor the performance of our products to ensure we meet customer expectations. Wehave recently received an increased number of complaints related to the display of Alert 402 on the CARTO® 3 System for cettain lots of.
- Biosense Webster, a J&J firm, has introduced its new CartoAlara Module for the company’s Carto 3 System, which combines live fluoroscopy images with those from the minimally invasive imaging.
- Webster I&+-P. CELSIUSM DS DiagnostidAblation Catheter INSTRUCTIONS FOR USE Caution: Federal (USA) law restricts this device to sale bv or on the order of a phvsician. SINGLE USE ONLY. DO NOT RESTERILE. DEVICE DESCRIPTION The Biosense Webster CELSIUS DS Diagnostic/Ablation Catheter (8 mm tip electrode) is a.
Jun 18, 2015 About Biosense Webster’s CARTO ® 3 System. The CARTO ® 3 System is an advanced imaging technology that utilizes electromagnetic technology to create real-time 3D maps of. Biosense Webster has released in the United States its new CARTO 3 MEM (Multi-Electrode Mapping) version of its 3D cardiac mapping system. The new model features multi-electrode catheters for high.
Apple iPad 2 Manual / User Guide This is the official Apple iPad 2 User Guide in English provided from the manufacturer. If you are looking for detailed technical specifications, please see our Specs page. Global Nav Open Menu Global Nav Close Menu; Apple; Shopping Bag. Apple ipad 2 16gb wifi.
Aug 22, 2010 From Biosense Webster. The CARTO 3 System is the next generation magnetic tracking 3D mapping system from Biosense Webster, building on the accuracy of CARTO System magnetic navigation technology. In February 2012, the MHRA issued a field safety notice for this device. Find out more here. This site is published by Biosense Webster, Inc. Which is solely responsible for its contents. This site is intended for English speaking employees of Biosense Webster, Inc. And its authorized agents residing in the United States, Canada, Latin America, Asia Pacific, Europe, Middle East and Africa regions. Yn 560 iii user manual pdf.
| 510(k) | | DeNovo | | Registration & Listing | | Adverse Events | | Recalls | | PMA | | HDE | | Classification | | Standards |
| CFR Title 21 | | Radiation-Emitting Products | | X-Ray Assembler | | Medsun Reports | | CLIA | | TPLC |
|
Lat Carto Mapping Biosense
| BIOSENSE WEBSTER, LTD (HAIFA, ISRAEL) CARTO 3 RMT SYSTEM COMPUTER, DIAGNOSTIC, PROGRAMMABLE | Back to Search Results |
| | Model Number M-5830-01 | | Event Date 08/16/2011 | | Event Type Malfunction | | Manufacturer Narrative | (b)(4). The problem has not occurred again following the complaint. The user saw no need for the testing to be done despite multiple follow ups from biosense field service engineers. No conclusion can be drawn as the user declined technical service. | | Event Description | Customer: (b)(4), 3d system: carto3 rf generator (stocker): manual mode (temperature cut off: 43) ablation catheter: navistar thermocool and celsius thermocool. After dr. (b)(6) mapped out (b)(6), he started to ablate the abnormal firing areas. There are some problems of system when dr. (b)(6) ablated abnormal area. We tried to increase power of stocker to ablate the abnormal firing areas but the temperature showed by stocker monitor did not change (30-34c) even power (30w-38w) increased. Dr. (b)(6) thought the temperature display was not correct and did not display real temperature of ablation areas. He worried that ablation areas of patient's heart were hurt by high temperature during ablation. So he changed ablation catheter (navistar to celsius) and changed the connection of catheter from carto3 piu to stocker. We found temperature showed by stocker (36-42c) was increased by power (28-34w) increased. As the reason dr. (b)(6) thought there are some problems of carto3 system when he did ablation by navistar thermocool. This problem happened 3 times in the same operation room with carto3 system. They also used carto xp to do the same procedure (paf ablation, same navistar thermocool, same manual mode of stocker), but this problem never happened. | | Manufacturer Narrative | The additional information from customer (affiliate): we did not report the event beside c3. The customer thinks c3 caused this event. They replaced new lot of navistar thermocool catheter and wait to see the event in next case. (b)(4). | | Search Alerts/Recalls |
|
|
Biosense Webster Cables
| New Search Submit an Adverse Event Report |
| Type of Device | COMPUTER, DIAGNOSTIC, PROGRAMMABLE |
|---|
| Manufacturer (Section D) | | BIOSENSE WEBSTER, LTD (HAIFA, ISRAEL) | | 4 hatnufah st. | | yokneam 2069 2 | | IS 20692 |
|
|---|
| Manufacturer (Section G) | | BIOSENSE WEBSTER, LTD (HAIFA, ISRAEL) | | 4 hatnufah st. | | yokneam 2069 2 | | IS 20692 |
|
|---|
| Manufacturer Contact | | jaime chavez | | 15715 arrow highway | | irwindale , CA 91706 | | 9098398483 |
|
|---|
| MDR Report Key | 2237307 |
|---|
| Report Number | 9681484-2011-00018 |
|---|
| Device Sequence Number | 1 |
|---|
| Product Code | DQK |
|---|
| Report Source | Manufacturer |
|---|
| Source Type | Foreign,User facility |
|---|
| Reporter Occupation |
|---|
| Type of Report | Initial,Followup |
|---|
| Report Date | 08/19/2011 |
|---|
| 1 Device Was Involved in the Event |
|---|
| 0 PatientS WERE Involved in the Event: |
|---|
| Date FDA Received | 09/07/2011 |
|---|
| Is This An Adverse Event Report? | No |
|---|
| Is This A Product Problem Report? | Yes |
|---|
| Device Operator | HEALTH PROFESSIONAL |
|---|
| Device MODEL Number | M-5830-01 |
|---|
| Device Catalogue Number | FG560000 |
|---|
| Was Device Available For Evaluation? | No |
|---|
| Is The Reporter A Health Professional? | No |
|---|
| Was the Report Sent to FDA? | No |
|---|
| Date Manufacturer Received | 08/16/2011 |
|---|
| Was Device Evaluated By Manufacturer? | Device Not Returned To Manufacturer |
|---|
| Is The Device Single Use? | No |
|---|
| Type of Device Usage | Initial |
|---|
|
|