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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 Failure to Read Input Signal (1581)
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 was unable to obtain an ecg signal via pads.Complainant indicated that there was no patient involvement in the reported malfunction.
 
Additional Manufacturer Narrative
Zoll medical corporation evaluated the device.The reported malfunction was not replicated or confirmed.The device was put through extensive testing, without duplicating the malfunction.The device was recertified and returned to the customer.No trend is associated with reports of this type.
 
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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 Key7798477
Report Number1220908-2018-02350
Device Sequence Number1143372
Product Code MKJ
UDI-Device Identifier00847946017651
UDI-Public00847946017651
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) 07/30/2018
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 Manufacturer08/02/2018
Was the Report Sent to FDA? No
Initial Date Received by Manufacturer 07/30/2018
Supplement Date Received by Manufacturer07/30/2018
Initial Report FDA Received Date08/20/2018
Supplement Report FDA Received Date08/30/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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