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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 malfunction was duplicated and evaluation of the device found that language software installed had become corrupted.The language software was re-installed to resolve the malfunction.It could not be firmly established how the software became corrupted.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 Key6648336
Report Number1220908-2017-01380
Device Sequence Number892185
Product Code MKJ
UDI-Device Identifier00847946006907
UDI-Public00847946006907
Combination Product (Y/N)N
Initial Reporter StateOH
Initial Reporter CountryUS
PMA/510(K) Number
K011541
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 05/31/2017
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 Other
Device Model NumberAED PLUS
Device Catalogue NumberAED PLUS
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/06/2017
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/31/2017
Initial Report FDA Received Date06/16/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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