HEARTSTART FRX 861304

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2014-02-19 for HEARTSTART FRX 861304 manufactured by Philips Medical Systems.

Event Text Entries

[4399750] It has been reported that the aed did not pass self diagnostic check
Patient Sequence No: 1, Text Type: D, B5


[11869937] (b)(4). Product evaluation pending. Issue is being reported as alert could not be cleared by operator. Date of manufacture: november 2009.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number3030677-2014-00602
MDR Report Key3823297
Report Source04
Date Received2014-02-19
Date of Report2014-02-06
Date Mfgr Received2014-02-06
Date Added to Maude2014-06-06
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional0
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactDARREN DEMERRITT
Manufacturer Street22100 BOTHELL EVERETT HWY
Manufacturer CityBOTHELL WA 980218431
Manufacturer CountryUS
Manufacturer Postal980218431
Manufacturer Phone4259082672
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameHEARTSTART FRX
Generic NameMJK
Product CodeMJK
Date Received2014-02-19
Model Number861304
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerPHILIPS MEDICAL SYSTEMS
Manufacturer Address22100 BOTHELL EVERETT HWY BOTHELL WA 98021843 US 98021 8431


Patients

Patient NumberTreatmentOutcomeDate
10 2014-02-19

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