FETAL MONITOR M1351A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2012-05-29 for FETAL MONITOR M1351A manufactured by Philips Medical Systems.

Event Text Entries

[2641488] The customer reported that the m1351a fetal monitor displayed error 601 after a fall. No pt harm was reported.
Patient Sequence No: 1, Text Type: D, B5


[9933782] (b)(4): the customer reported that the m1351a fetal monitor displayed error 601 after a fall. There is not sufficient info to determine if this monitor fell from a mount. Philips is in the process of obtaining additional info concerning this event and the complaint is still under investigation. A final report will be submitted once the investigation is completed.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number9610816-2012-00252
MDR Report Key2595304
Report Source05,06,07
Date Received2012-05-29
Date of Report2012-04-30
Date Mfgr Received2012-04-30
Device Manufacturer Date1997-04-01
Date Added to Maude2012-10-01
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 ContactDENYSE MURPHY
Manufacturer Street3000 MINUTEMAN RD
Manufacturer CityANDOVER MA 01810
Manufacturer CountryUS
Manufacturer Postal01810
Manufacturer Phone9786597844
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameFETAL MONITOR
Product CodeHFM
Date Received2012-05-29
Model NumberM1351A
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerPHILIPS MEDICAL SYSTEMS
Manufacturer Address3000 MINUTEMAN RD ANDOVER MA 01810 US 01810


Patients

Patient NumberTreatmentOutcomeDate
10 2012-05-29

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