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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION AED PLUS; DEFIBRILLATOR
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ZOLL MEDICAL CORPORATION AED PLUS; DEFIBRILLATOR Back to Search Results
Model Number AED PLUS
Medical Device Problem Code Failure to Power Up (1476)
Health Effect - Clinical Code No Patient Involvement (2645)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The device was returned to zoll medical corporation for evaluation.During disassembly of the device to determine root cause, the technician observed damage to the internal main board and external parts consistent with mis-handling.Component root cause could not be firmly established due to the observed damage.The main board and external parts were replaced.The device was recertified and returned to the customer.Analysis of reports of this type has not identified an increase in trend.
 
Event or Problem Description
Complainant alleged that during functional testing, the device would not power up.Complainant indicated that there was no patient involvement in the reported malfunction.
 
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Brand Name
AED PLUS
Common Device Name
DEFIBRILLATOR
Manufacturer (Section D)
ZOLL MEDICAL CORPORATION
269 mill road
chelmsford MA 01824
MDR Report Key9917942
Report Number1220908-2020-00882
Device Sequence Number2814538
Product Code MKJ
UDI-Device Identifier00847946002169
UDI-Public00847946002169
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
PMA/510(K) Number
K011541/P160
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 03/12/2020
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 Health Professional
Device Model NumberAED PLUS
Device Catalogue NumberAED PLUS
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/17/2020
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/12/2020
Initial Report FDA Received Date04/02/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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