R SERIES DEFIBRILLATOR

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 R SERIES DEFIBRILLATOR manufactured by Zoll Medical Corporation.

Event Text Entries

[185794167] 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


[185794168] Complainant alleged that during functional testing, the device displayed "defib disabled"and "pacer disabled" messages. Complainant did not indicate that there was any patient involvement in the reported malfunction.
Patient Sequence No: 1, Text Type: D, B5


[187679669] The customer's report was observed and attributed to the analog board. Loose snap hooks caused the top shield to become disconnected from the analog board. The device was recertified and returned to the customer. Analysis of reports of this type has not identified an increase in trend.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1220908-2020-00822
MDR Report Key9904408
Date Received2020-03-31
Date of Report2020-03-10
Date Mfgr Received2020-03-10
Device Manufacturer Date2018-05-01
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 Mfg2020-03-16
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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