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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 Smoking (1585); Noise, Audible (3273)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/05/2017
Event Type  malfunction  
Manufacturer Narrative
Manufacturer's reference number: (b)(4) it was reported that a carto 3 system stated to smoke. The workstation was replaced by the clinical account specialist, and the replacement workstation was installed, tested, and left ready for clinical use. The defective workstation was sent to htc (device manufacturer) for further investigation. The power supply was found to have failed, causing the reported issue. The power supply was replaced, returning the workstation to normal operation. A device history record (dhr) review was performed by the manufacturer, and no anomalies related to the reported issue were noted in the manufacturing or servicing of this equipment. The customer complaint was confirmed.
 
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 carto 3 system stated to smoke. No procedure was taking place. After turning on the carto system, a bang was heard, and smoke started to come out of the workstation's power unit. There was no harm to patient or staff. Burning or the presence of smoke presents the risk of fire, which could potentially cause injuries to the patient or staff. As a result, this event is mdr reportable.
 
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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 Key6681341
MDR Text Key251143432
Report Number3008203003-2017-00027
Device Sequence Number1
Product Code DQK
Combination Product (y/n)N
Reporter Country CodeSP
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 06/05/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/30/2017
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 Received06/05/2017
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

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