OBTV SERVER M1383D

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 2012-04-17 for OBTV SERVER M1383D manufactured by Philips Med Systems.

Event Text Entries

[20317281] The customer reported that the alarms were not functioning on their devices. No pt harm was reported.
Patient Sequence No: 1, Text Type: D, B5


[20541537] (b)(4). The customer reported that the alarms were not functioning on their devices. No pt harm was reported. Due to the allegation that the alarms did not work and since a user might not be aware that the alarms are not functioning, philips reporting this incident. Based on the initial info provided, philips considers that this is not a malfunction of the device. 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 Number9610816-2012-00183
MDR Report Key2549767
Report Source05,06,07
Date Received2012-04-17
Date of Report2012-04-06
Date Mfgr Received2012-04-06
Device Manufacturer Date2008-08-01
Date Added to Maude2012-09-12
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 ContactNANCY ATAIDE
Manufacturer Street3000 MINUTEMAN RD
Manufacturer CityANDOVER MA 01810
Manufacturer CountryUS
Manufacturer Postal01810
Manufacturer Phone9786597429
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameOBTV SERVER
Product CodeHFM
Date Received2012-04-17
Model NumberM1383D
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerPHILIPS MED SYSTEMS
Manufacturer Address3000 MINUTEMAN RD ANDOVER MA 01810 US 01810


Patients

Patient NumberTreatmentOutcomeDate
10 2012-04-17

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