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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 of Device to Self-Test (2937)
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 functional testing, the device prompted a "unit failed" message.Complainant indicated that there was no patient involvement in the reported malfunction.
 
Additional Manufacturer Narrative
Zoll medical corporation evaluated the device and the device performed to specification.The customer received a replacement device.Review of the device activity logs showed no evidence to confirm a unit failed in recuse mode.This has been closed as report unsubstantiated.Analysis of reports of this type has not identified an increase in trend.
 
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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 Key7248340
Report Number1220908-2018-00296
Device Sequence Number100839
Product Code MKJ
UDI-Device Identifier00847946015640
UDI-Public00847946015640
Combination Product (Y/N)N
Initial Reporter CountryAU
PMA/510(K) Number
K011541
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) 01/18/2018
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 NumberAED PLUS
Device Catalogue NumberAED PLUS
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/29/2018
Initial Date Received by Manufacturer 01/18/2018
Supplement Date Received by Manufacturer01/18/2018
Initial Report FDA Received Date02/07/2018
Supplement Report FDA Received Date02/23/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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