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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 No Display/Image (1183)
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 functional testing, the device powered on without display.Complainant did not indicate that there was any patient involvement in the reported malfunction.
 
Additional Manufacturer Narrative
The device was returned to zoll medical corporation; the customer's report was duplicated and the lcd display module was replaced to resolve the report.The device was recertified and returned to the customer.Analysis of reports of this type has not identified anincrease 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 Key10289571
Report Number1220908-2020-02108
Device Sequence Number19677164
Product Code MKJ
UDI-Device Identifier00847946017644
UDI-Public00847946017644
Combination Product (Y/N)N
Initial Reporter StateAZ
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) 06/26/2020
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 Manufacturer07/07/2020
Was the Report Sent to FDA? No
Initial Date Received by Manufacturer 06/26/2020
Supplement Date Received by Manufacturer06/26/2020
Initial Report FDA Received Date07/17/2020
Supplement Report FDA Received Date08/04/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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