MP5 M8105A (865024)

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-09 for MP5 M8105A (865024) manufactured by Philips Medical Systems.

Event Text Entries

[107839319]
Patient Sequence No: 1, Text Type: N, H10


[107839320] The customer reported that "the patient's heart stopped for 8 seconds and the mp5 did not alarm at all". The device was used for monitoring at the time of the alleged malfunction. The heart of the (b)(6) year-old male patient with a weight of (b)(6) kilos stopped beating for 8 seconds and then started beating again without medical intervention. The customer's biomedical engineer stated that the patient was fine after the occurrence. No death or patient injury or harm was reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9610816-2018-00112
MDR Report Key7498406
Date Received2018-05-09
Date of Report2018-04-10
Date Mfgr Received2018-04-10
Device Manufacturer Date2012-07-25
Date Added to Maude2018-05-09
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 ContactMS. BETTY HARRIS
Manufacturer StreetHEWLETT-PACKARD STR.2
Manufacturer CityBOEBLINGEN 71034
Manufacturer CountryGM
Manufacturer Postal71034
Manufacturer G1PHILIPS MEDICAL SYSTEMS
Manufacturer Street3000 MINUTEMAN ROAD
Manufacturer CityANDOVER MA 01810
Manufacturer CountryUS
Manufacturer Postal Code01810
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameMP5
Generic NamePATIENT MONITOR
Product CodeBZQ
Date Received2018-05-09
Model NumberM8105A (865024)
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerPHILIPS MEDICAL SYSTEMS
Manufacturer AddressHEWLETT-PACKARD STR.2 BOEBLINGEN 71034 GM 71034


Patients

Patient NumberTreatmentOutcomeDate
10 2018-05-09

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