POLY-C-OMCP-VISUB(H3000) 72238 NA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2011-02-10 for POLY-C-OMCP-VISUB(H3000) 72238 NA manufactured by Philips Healthcare.

Event Text Entries

[16096067] (b)(4). This event is still under investigation. The follow-up report will be sent by (b)(4) 2011.
Patient Sequence No: 1, Text Type: N, H10


[16323451] The customer states that "the unit shut down when a patient was on the table".
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3003768277-2011-00113
MDR Report Key2020569
Report Source07
Date Received2011-02-10
Date of Report2011-01-13
Date Mfgr Received2011-01-13
Date Added to Maude2011-04-01
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 ContactANTHONY PERRY
Manufacturer Street595 MINER RD
Manufacturer CityCLEVELAND OH 44143
Manufacturer CountryUS
Manufacturer Postal44143
Manufacturer Phone4404832025
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePOLY-C-OMCP-VISUB(H3000)
Generic NameNA
Product CodeIZF
Date Received2011-02-10
Model Number72238
Catalog NumberNA
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
10 2011-02-10

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