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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WIPRO GE HEALTHCARE PRIVATE LTD. MAC 1200 ELECTROCARDIOGRAPH

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WIPRO GE HEALTHCARE PRIVATE LTD. MAC 1200 ELECTROCARDIOGRAPH Back to Search Results
Device Problems Power Cord (497); Fire (1245); Smoking (1585); Use of Device Problem (1670)
Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
Event Type  Malfunction  
Manufacturer Narrative

Device was not in patient use. Incident date: information not provided by customer. The customer is located outside of the usa and therefore, this information is not provided due to country privacy laws. Device manufacture date information not available at this time. Ge healthcare's investigation is ongoing. A follow up report will be submitted when the investigation is complete. Device evaluation anticipated, but not yet begun.

 
Event Description

The customer alleged smoke and small fire on the main power cord of mac 1200. The device was not in use therefore, no patient injury.

 
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Brand NameMAC 1200
Type of DeviceELECTROCARDIOGRAPH
Manufacturer (Section D)
WIPRO GE HEALTHCARE PRIVATE LTD.
4, kadugodi industrial area
bangalore 56006 7
IN 560067
Manufacturer Contact
kristof soos
8200 w tower avenue
milwaukee, WI 
MDR Report Key9234255
MDR Text Key170435819
Report Number9617277-2019-00004
Device Sequence Number1
Product Code DPS
Combination Product (Y/N)N
PMA/PMN NumberK042177
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,USER FACILITY
Type of Report Initial,Followup
Report Date 12/19/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/24/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/03/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/01/1970
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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