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 2010-10-07 for FETAL MONITOR M1351A manufactured by Philips Medical Systems.

Event Text Entries

[1695370] The customer reported that the device fell.
Patient Sequence No: 1, Text Type: D, B5


[8686935] (b)(4). It is reported that the device fell. It was not reported if the customer dropped the device or if there was an insufficient mounting. There is not sufficient info to determine if the device was mounted incorrectly or if it was a user error. No adverse impact to any pt or user was reported. Philips is in the process of obtaining additional info regarding this incident 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 Number9610816-2010-00577
MDR Report Key1867773
Report Source05,06,07
Date Received2010-10-07
Date of Report2010-09-08
Date Mfgr Received2010-09-08
Device Manufacturer Date1996-02-01
Date Added to Maude2011-02-17
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 ContactGREG THEOKAS
Manufacturer Street3000 MINUTEMAN RD
Manufacturer CityANDOVER MA 01810
Manufacturer CountryUS
Manufacturer Postal01810
Manufacturer Phone9786871501
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameFETAL MONITOR
Product CodeHFM
Date Received2010-10-07
Model NumberM1351A
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
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 2010-10-07

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