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U.S. Department of Health and Human Services

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

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BIOSENSE WEBSTER (ISRAEL) LTD. CARTO® 3 SYSTEM COMPUTER, DIAGNOSTIC, PROGRAMMABLE Back to Search Results
Model Number M-4800-01
Device Problems Device Operates Differently Than Expected (2913); Noise, Audible (3273)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/28/2016
Event Type  malfunction  
Manufacturer Narrative
The hardware 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. (b)(4).
 
Event Description
It was reported that a patient underwent a procedure with a carto 3 system and all body surface and intercardiac signals had noise on both the carto 3 system and the recording system. No signals were able to be seen. The only source of vital data was the pressure curve on a second system. The procedure could be completed without further issues as the noise disappeared as soon as the pacing channel on the carto 3 system was closed. There was no patient consequence. The lack of monitoring of the cardiac rhythm while devices are intracardiac was assessed as a reportable malfunction as it may lead to an undetected cardiac rhythm that can be life threatening.
 
Manufacturer Narrative
(b)(4). It was reported that a patient underwent a procedure with a carto 3 system and all body surface and intercardiac signals had noise on both the carto 3 system and the recording system. No signals were able to be seen. The only source of vital data was the pressure curve on a second system. The procedure could be completed without further issues as the noise disappeared as soon as the pacing channel on the carto 3 system was closed. There was no patient consequence. Backplane was replaced successfully. Atp/preventative maintenance was performed successfully. System is running according to the specification and is ready for clinical use. Backplane was sent to the device manufacturer for investigation and the customer's complaint was not confirmed. Backplane card was tested and found operable. No issue was found during the backplane investigation. The device history record (dhr) review was performed by the manufacturer and no anomalies were noted in manufacturing or servicing of this equipment.
 
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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 Key5665612
MDR Text Key46696147
Report Number3008203003-2016-00016
Device Sequence Number1
Product Code DQK
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K133916
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/28/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/19/2016
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? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/28/2016
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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