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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION PROPAQ MD DEFIBRILLATOR
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ZOLL MEDICAL CORPORATION PROPAQ MD DEFIBRILLATOR 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 received the product and will be providing a supplemental report when our investigation is completed.
 
Event or Problem Description
Complainant alleged that during a routine shift check by a clinician, the device failed self-test for pacer function.Complainant indicated that there was no patient involvement in the reported malfunction.
 
Additional Manufacturer Narrative
The device was returned to zoll medical corporation; the customer's report was observed and attributed to a damaged transformer on the processor/bridge/pace board.The device was recertified and returned to the customer.Analysis for reports of this type has not identified an increase in trend.
 
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Brand Name
PROPAQ MD DEFIBRILLATOR
Common Device Name
PROPAQ MD
Manufacturer (Section D)
ZOLL MEDICAL CORPORATION
269 mill road
chelmsford MA 01824
MDR Report Key10025773
Report Number1220908-2020-01247
Device Sequence Number14232320
Product Code MKJ
UDI-Device Identifier00847946017644
UDI-Public00847946017644
Combination Product (Y/N)N
Initial Reporter StateGA
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) 04/14/2020
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 Manufacturer04/23/2020
Was the Report Sent to FDA? No
Initial Date Received by Manufacturer 04/14/2020
Supplement Date Received by Manufacturer04/14/2020
Initial Report FDA Received Date05/05/2020
Supplement Report FDA Received Date06/25/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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