PLY C-OMCP-VISUB (H3000) 72238

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2011-08-04 for PLY C-OMCP-VISUB (H3000) 72238 manufactured by Philips Healthcare.

Event Text Entries

[22232085] Philips was informed that a pt died after injection of air by an injector. Information was received on (b)(6), via an external source, independent of the hospital and unrelated to philips which leads philips to the conclusion that an adverse event incident has occurred earlier at a site where our engineer, apparently, shortly after the incident occurred was requested to check the functionality of the injector connected to one of our x-ray systems.
Patient Sequence No: 1, Text Type: D, B5


[22259271] (b)(4). When investigation is completed, a follow-up report will be sent to the fda.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number3003768277-2011-00447
MDR Report Key2196413
Report Source01,07
Date Received2011-08-04
Date of Report2011-07-05
Date of Event2011-01-01
Date Mfgr Received2011-07-05
Date Added to Maude2011-08-11
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 ContactDOMINIC SIEWKO
Manufacturer Street3000 MINUTEMAN DRIVE
Manufacturer CityANDOVER MA 01810
Manufacturer CountryUS
Manufacturer Postal01810
Manufacturer Phone9786597936
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePLY C-OMCP-VISUB (H3000)
Product CodeIZF
Date Received2011-08-04
Model Number72238
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerPHILIPS HEALTHCARE
Manufacturer AddressVEENPLUIS 4-6 BEST 5680DA NL 5680 DA


Patients

Patient NumberTreatmentOutcomeDate
101. Death 2011-08-04

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