AED PLUS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-31 for AED PLUS manufactured by Zoll Medical Corporation.

Event Text Entries

[185794206] Zoll medical corporation has not received the device for evaluation and this complaint is still under investigation.
Patient Sequence No: 1, Text Type: N, H10


[185794207] Complainant alleged that during functional testing, the device would not power up. Complainant indicated that there was no patient involvement in the reported malfunction.
Patient Sequence No: 1, Text Type: D, B5


[188939960] The customer was contacted for return of the suspect product. The product has not been returned to zoll for evaluation.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1220908-2020-00807
MDR Report Key9904511
Date Received2020-03-31
Date of Report2020-03-10
Date Mfgr Received2020-03-10
Device Manufacturer Date2019-01-01
Date Added to Maude2020-03-31
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer Street269 MILL ROAD
Manufacturer CityCHELMSFORD MA 01824
Manufacturer CountryUS
Manufacturer Postal01824
Manufacturer Phone9784219552
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameAED PLUS
Generic NameDEFIBRILLATOR
Product CodeMKJ
Date Received2020-03-31
Model NumberAED PLUS
Catalog NumberAED PLUS
Lot NumberNA
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerZOLL MEDICAL CORPORATION
Manufacturer Address269 MILL ROAD CHELMSFORD MA 01824 US 01824


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-31

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