FETAL MONITOR M1351A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06 report with the FDA on 2014-05-01 for FETAL MONITOR M1351A manufactured by Philips Medical Systems.

Event Text Entries

[4454297] The customer reported that "it does not trace the right variability". No patient harm was reported.
Patient Sequence No: 1, Text Type: D, B5


[11873345] (b)(4). A follow up report will be submitted upon completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number9610816-2014-00111
MDR Report Key3823476
Report Source01,06
Date Received2014-05-01
Date of Report2014-04-08
Date Mfgr Received2014-04-08
Device Manufacturer Date2004-12-01
Date Added to Maude2014-06-20
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 ContactDENYSE MURPHY
Manufacturer Street3000 MINUTEMAN ROAD
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 Received2014-05-01
Model NumberM1351A
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerPHILIPS MEDICAL SYSTEMS
Manufacturer AddressHEWLETT-PACKARD STR.2 BOEBLINGEN 71034 GM 71034


Patients

Patient NumberTreatmentOutcomeDate
10 2014-05-01

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