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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
Device Problem Sparking (2595)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
Zoll medical corporation evaluated the device and the reported malfunction was not replicated or confirmed. The device was put through extensive testing which included battery insertion test, bench handling, functional stress testing without duplicating the malfunction. The battery compartment showed no signs of the customer? report during visual inspection. The device was recertified and returned to the customer. It's important to mention that the batteries and battery cover used during the time of the event were not returned for evaluation as part of the investigation. No trend is associated with reports of this type.
 
Event Description
Complainant alleged that during biomed testing, sparks appeared near the battery housing. Complainant indicated that there was no patient involvement in the reported malfunction.
 
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Brand NameAED PLUS
Type of DeviceDEFIBRILLATOR
Manufacturer (Section D)
ZOLL MEDICAL CORPORATION
269 mill road
chelmsford MA 01824
Manufacturer Contact
269 mill road
chelmsford, MA 01824
9784219552
MDR Report Key8091222
MDR Text Key127945696
Report Number1220908-2018-03351
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K011541/P160
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Reporter Occupation
Type of Report Initial
Report Date 10/30/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/20/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberAED PLUS
Device Catalogue NumberAED PLUS
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/07/2018
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/30/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/01/2011
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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