POLY 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 POLY C-OMCP-VISUB (H3000) 72238 manufactured by Philips Healthcare.

Event Text Entries

[1998984] The customer reported that during operation an error occurred stating "that frontal generator was not available. "
Patient Sequence No: 1, Text Type: D, B5


[9148424] (b)(4). The field service engineer (fse) troubleshot the system and found a problem there was an intermittent error in the communication between the generator and the tube. He replaced the printed circuit board (serial data link) responsible for communication between generator and tube, this solved the problem. The system was last produced in 1998, and was declared end of life as of 2010.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number3003768277-2011-00482
MDR Report Key2199674
Report Source01,07
Date Received2011-08-04
Date of Report2011-07-06
Date Mfgr Received2011-07-06
Date Added to Maude2011-09-23
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 DR.
Manufacturer CityANDOVER MA 01810
Manufacturer CountryUS
Manufacturer Postal01810
Manufacturer Phone9786597936
Single Use3
Remedial ActionRL
Previous Use Code3
Event Type3
Type of Report3

Device Details

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


Patients

Patient NumberTreatmentOutcomeDate
10 2011-08-04

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