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 2018-11-05 for HEARTSTART ONSITE M5066A manufactured by Philips Medical Systems.

Event Text Entries

[126221181]
Patient Sequence No: 1, Text Type: N, H10


[126221182] It has been reported that the device is failing self-test.
Patient Sequence No: 1, Text Type: D, B5


[137110168] This case was previously reported on pr 8780453 with mdr #3030677-2018-02661. The investigation has been completed.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number3030677-2018-02479
MDR Report Key8038848
Date Received2018-11-05
Date of Report2018-10-10
Date Mfgr Received2018-10-10
Device Manufacturer Date2018-03-01
Date Added to Maude2018-11-05
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 BLDG A
Manufacturer CityBOTHELL WA 980218431
Manufacturer CountryUS
Manufacturer Postal980218431
Manufacturer Phone8887445477
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Sequence Number: 0

Brand NameHEARTSTART ONSITE
Generic NameAED
Product CodeMLN
Date Received2018-11-05
Model NumberM5066A
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrN
Device Sequence No0
Device Event Key0
ManufacturerPHILIPS MEDICAL SYSTEMS
Manufacturer Address22100 BOTHELL EVERETT HWY BOTHELL WA 980218431 US 980218431

Device Sequence Number: 1

Brand NameHEARTSTART ONSITE
Generic NameAED
Product CodeMLN
Date Received2018-11-05
Model NumberM5066A
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 980218431 US 980218431


Patients

Patient NumberTreatmentOutcomeDate
10 2018-11-05

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