R SERIES DEFIBRILLATOR

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2020-03-31 for R SERIES DEFIBRILLATOR manufactured by Zoll Medical Corporation.

Event Text Entries

[185797030] Zoll medical corporation has received the product and will be providing a supplemental report when our investigation is completed.
Patient Sequence No: 1, Text Type: N, H10


[185797031] Complainant alleged that during biomed testing, the device inappropriately shut down. Complainant indicated that there was no patient involvement in the reported malfunction.
Patient Sequence No: 1, Text Type: D, B5


[188004687] The device was returned to zoll medical corporation; the customer's report was observed during review of the device's history log. The device was put through extensive testing including bench handling, power cycling, full functionality, and stress testing. Without duplicating the report. The digital board was replaced as a precaution. The device passed the final test procedure, was recertified, and returned to the customer. Analysis for reports of this type has not identified an increase in trend.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1220908-2020-00801
MDR Report Key9903646
Report SourceFOREIGN
Date Received2020-03-31
Date of Report2020-03-10
Date Mfgr Received2020-03-10
Device Manufacturer Date2017-03-01
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 NameR SERIES DEFIBRILLATOR
Generic NameDEFIBRILLATOR/PACEMAKER
Product CodeMKJ
Date Received2020-03-31
Returned To Mfg2020-03-19
Model NumberR SERIES
Catalog NumberR SERIES
Lot NumberNA
Device AvailabilityR
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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