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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 Deliver (2338)
Health Effect - Clinical Code No Patient Involvement (2645)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Zoll medical corporation has not received the device and this complaint is still under investigation.
 
Event or Problem Description
Complainant alleged that during biomed testing, the device displayed "internal error" message.Complainant indicated that there was no patient involvement in the reported malfunction.
 
Additional Manufacturer Narrative
The device was returned to zoll medical corporation; the malfunction was duplicated and attributed to the monitor board.The monitor board was replaced to remedy the problem.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 Key7957666
Report Number1220908-2018-02971
Device Sequence Number16193764
Product Code MKJ
UDI-Device Identifier00847946017699
UDI-Public00847946017699
Combination Product (Y/N)N
PMA/510(K) Number
K100654
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source foreign
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 09/21/2018
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 Manufacturer10/03/2018
Was the Report Sent to FDA? No
Initial Date Received by Manufacturer 09/21/2018
Supplement Date Received by Manufacturer09/21/2018
Initial Report FDA Received Date10/11/2018
Supplement Report FDA Received Date11/05/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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