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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 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.
 
Manufacturer Narrative
Investigation revealed that there was only a burn smell and no fire, as reported by customer.The damaged/broken power cord which only a had a â molded markâ쳌, was also found to be be a non-ge power cord and not a ge approved part.It was confirmed that there was no device malfunction with the mac 1200 and this issue was due to the improper power cord.
 
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Brand Name
MAC 1200
Type of Device
ELECTROCARDIOGRAPH
Manufacturer (Section D)
WIPRO GE HEALTHCARE PRIVATE LTD.
4, kadugodi industrial area
bangalore 56006 7
IN  560067
MDR Report Key9234255
MDR Text Key170435819
Report Number9617277-2019-00004
Device Sequence Number1
Product Code DPS
Combination Product (y/n)N
PMA/PMN Number
K042177
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
1 Patient was 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
Date Manufacturer Received12/03/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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