• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOSENSE WEBSTER (ISRAEL) LTD. CARTO® 3 SYSTEM COMPUTER, DIAGNOSTIC, PROGRAMMABLE

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
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
 

BIOSENSE WEBSTER (ISRAEL) LTD. CARTO® 3 SYSTEM COMPUTER, DIAGNOSTIC, PROGRAMMABLE Back to Search Results
Model Number M-4800-01
Device Problems Device Alarm System (1012); Positioning Problem (3009)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/19/2016
Event Type  malfunction  
Manufacturer Narrative
The investigation has begun but it has not been completed at this time. When the investigational analysis has been completed, a supplemental 3500a report will be submitted. Contact office and manufacturing site should reflect: (b)(4).
 
Event Description
It was reported that a map shift of approximately 1-2cm occurred with use of the carto system while at the ablation phase of the procedure. There were no error messages, no patient movement, and no cardioversion had been performed. This is mdr reportable as map shifts without error or warning message could be potentially caused by system malfunction and posed potential risk to patient.
 
Manufacturer Narrative
(b)(4). It was reported that there was a map shift but there were no warnings or error messages displayed on the carto 3 system. Clinical account specialist confirmed that case has already been backed up and removed from the database, therefore data cannot be retrieved for analysis. The provided data is lack with information, based on the available information the root cause of the failure cannot be determined. In addition the customer also declined service since this was a one time occurence and has not happened since complaint was reported. Issue was not duplicated. The history of customer complaints associated with carto 3 system #14569 was reviewed. 1 out of 3 additional reported complaints may be related to the reported issue. Dhr review was performed by the manufacturer and no anomalies were noted in manufacturing or servicing of this equipment.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameCARTO® 3 SYSTEM
Type of DeviceCOMPUTER, DIAGNOSTIC, PROGRAMMABLE
Manufacturer (Section D)
BIOSENSE WEBSTER (ISRAEL) LTD.
4 hatnufah street
yokneam 20667 17
IS 2066717
Manufacturer (Section G)
BIOSENSE WEBSTER (ISRAEL) LTD.
4 hatnufah street
yokneam 20667 17
IS 2066717
Manufacturer Contact
joaquin kurz
33 technology drive
irvine, CA 92618
9497893837
MDR Report Key5729466
MDR Text Key48510459
Report Number3008203003-2016-00025
Device Sequence Number1
Product Code DQK
Combination Product (y/n)N
PMA/PMN Number
K133916
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/19/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/16/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberM-4800-01
Device Catalogue NumberFG540000
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/19/2016
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Reuse

-
-