R SERIES DEFIBRILLATOR

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2014-06-04 for R SERIES DEFIBRILLATOR manufactured by Zoll Medical Corporation.

Event Text Entries

[4623206] Complainant alleged that during a routine shift check by a clinician, the device's display was distorted and clinical information could not be seen. Complainant indicated that there was no patient involvement in the reported malfunction.
Patient Sequence No: 1, Text Type: D, B5


[12057783] Zoll medical corporation has received the device for evaluation and this complaint is still under investigation.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1220908-2014-01347
MDR Report Key3966220
Report Source99
Date Received2014-06-04
Date of Report2014-05-19
Date Mfgr Received2014-05-19
Device Manufacturer Date2007-10-01
Date Added to Maude2014-08-06
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 FDA0
Event Location0
Manufacturer ContactSCOTT AUGUST
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 CodeLIX
Date Received2014-06-04
Returned To Mfg2014-06-03
Model NumberR SERIES
Catalog NumberR SERIES
Lot NumberNA
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerZOLL MEDICAL CORPORATION
Manufacturer AddressCHELMSFORD MA US


Patients

Patient NumberTreatmentOutcomeDate
10 2014-06-04

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