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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION AED3; DEFIBRILLATOR
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ZOLL MEDICAL CORPORATION AED3; DEFIBRILLATOR Back to Search Results
Model Number AED3
Device Problem Failure of Device to Self-Test (2937)
Patient Problem Insufficient Information (4580)
Event Type  malfunction  
Manufacturer Narrative
Zoll medical corporation has received the product and will be providing a supplemental report when our investigation is completed.
 
Event Description
Complainant alleged that during functional testing, the device failed self test.Complainant indicated that there was no patient involvement in the reported malfunction.
 
Manufacturer Narrative
The device was returned to zoll medical corporation and the customer's report was not replicated or confirmed.The device was put through extensive testing without duplicating the report.The device was recertified and returned to the customer.Review of the device logs showed no critical errors.The electrode pads and battery involved were not returned as part of this investigation.No trend is associated with reports of this type.
 
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Brand Name
AED3
Type of Device
DEFIBRILLATOR
Manufacturer (Section D)
ZOLL MEDICAL CORPORATION
269 mill road
chelmsford MA 01824
MDR Report Key12586488
MDR Text Key275914572
Report Number1220908-2021-03320
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
PMA/PMN Number
P160022
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Type of Report Initial,Followup
Report Date 09/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/06/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberAED3
Device Catalogue NumberAED3
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/01/2021
Was the Report Sent to FDA? No
Date Manufacturer Received09/15/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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