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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 No Display/Image (1183)
Health Effect - Clinical Code No Patient Involvement (2645)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The device was returned to zoll medical corporation; the malfunction was duplicated and the device's lcd display cable was replaced to resolve the malfunction.Analysis for reports of this type has not identified an increase in trend.
 
Event or Problem Description
Complainant alleged that during a routine shift check by a clinician, the device powered up without display.Complainant indicated that there was no patient involvement in the reported malfunction.
 
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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 Key6450270
Report Number1220908-2017-00724
Device Sequence Number875212
Product Code MKJ
UDI-Device Identifier00847946017675
UDI-Public00847946017675
Combination Product (Y/N)N
Initial Reporter StateMD
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
Report Date (Section B) 03/20/2017
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 Health Professional
Device Model NumberPROPAQ MD
Device Catalogue NumberPROPAQ MD
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/22/2017
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/20/2017
Initial Report FDA Received Date03/31/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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