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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION PROPAQ MD DEFIBRILLATOR; DEFIBRILLATOR/PACEMAKER
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ZOLL MEDICAL CORPORATION PROPAQ MD DEFIBRILLATOR; DEFIBRILLATOR/PACEMAKER Back to Search Results
Model Number PROPAQ MD
Medical Device Problem Code Failure of Device to Self-Test (2937)
Health Effect - Clinical Code No Patient Involvement (2645)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Zoll medical corporation has not received the device for evaluation and this complaint is still under investigation.
 
Event or Problem Description
Complainant alleged that during biomed testing, the device failed self-test for defib function.Complainant indicated that there was no patient involvement in the reported malfunction.
 
Additional Manufacturer Narrative
The reported malfunction was observed and attributed to a faulty transformer on the processor/bridge/pace board.Analysis of reports of this type has not identified an increase in trend.
 
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Brand Name
PROPAQ MD DEFIBRILLATOR
Common Device Name
DEFIBRILLATOR/PACEMAKER
Manufacturer (Section D)
ZOLL MEDICAL CORPORATION
269 mill road
chelmsford MA 01824
MDR Report Key6889762
Report Number1220908-2017-02311
Device Sequence Number13628059
Product Code MKJ
UDI-Device Identifier00847946017682
UDI-Public00847946017682
Combination Product (Y/N)N
Initial Reporter StateFL
Initial Reporter CountryUS
PMA/510(K) Number
K100654
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 09/05/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Other
Device Model NumberPROPAQ MD
Device Catalogue NumberPROPAQ MD
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/27/2017
Initial Date Received by Manufacturer 09/05/2017
Supplement Date Received by Manufacturer09/05/2017
Initial Report FDA Received Date09/25/2017
Supplement Report FDA Received Date11/28/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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