HEARTSTART ONSITE M5066A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-29 for HEARTSTART ONSITE M5066A manufactured by Philips Medical Systems.

Event Text Entries

[146499645] .
Patient Sequence No: 1, Text Type: N, H10


[146499646] It has been reported that the device is failing self-test.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3030677-2019-01133
MDR Report Key8651963
Date Received2019-05-29
Date of Report2019-05-23
Date Mfgr Received2019-05-23
Device Manufacturer Date2018-01-31
Date Added to Maude2019-05-29
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 ContactMISS SHANNON DECKER
Manufacturer Street22100 BOTHELL EVERETT HWY
Manufacturer CityBOTHELL WA 98021
Manufacturer CountryUS
Manufacturer Postal98021
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameHEARTSTART ONSITE
Generic NameAED
Product CodeMLN
Date Received2019-05-29
Model NumberM5066A
Lot NumberY121417-02
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerPHILIPS MEDICAL SYSTEMS
Manufacturer Address22100 BOTHELL EVERETT HWY BOTHELL WA 98021 US 98021


Patients

Patient NumberTreatmentOutcomeDate
10 2019-05-29

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.