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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 to Select Signal (1582)
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 functional testing, the device was unable to select energy level.Complainant did not indicate that there was any patient involvement in the reported malfunction.
 
Additional Manufacturer Narrative
The device was evaluated by a certified zoll service provider; the malfunction was duplicated and the front enclosure was replaced to resolve the malfunction.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 Key8808946
Report Number1220908-2019-01996
Device Sequence Number11436279
Product Code MKJ
UDI-Device Identifier00847946017705
UDI-Public00847946017705
Combination Product (Y/N)N
Initial Reporter CountryCH
PMA/510(K) Number
K100654
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source distributor,foreign
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 06/28/2019
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? No
Was the Report Sent to FDA? No
Initial Date Received by Manufacturer 06/28/2019
Supplement Date Received by Manufacturer06/28/2019
Initial Report FDA Received Date07/19/2019
Supplement Report FDA Received Date08/29/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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