INTEGRIS 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 2010-11-17 for INTEGRIS H3000 72238 NA manufactured by Philips Medical Systems.

Event Text Entries

[1677440] The customer reported that this x-ray system stopped during an examination with a pt on the table. The system would not restart.
Patient Sequence No: 1, Text Type: D, B5


[8905147] (conclusions) - method and results (other) - this system problem was solved by replacing several hardware components. The exact root cause is unk. The system was repaired by the replacement of several hardware components which might have contributed to the reported problem. None of these components have exceptional or increased failure rates. The failure rates are monitored for these components. Therefore, risk to pt remains acceptable. (b)(4).
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number3003768277-2010-00310
MDR Report Key1912519
Report Source07
Date Received2010-11-17
Date of Report2010-10-21
Date of Event2010-10-21
Date Mfgr Received2010-10-21
Date Added to Maude2011-03-07
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 ContactDREW QUEEN
Manufacturer Street22100 BOTHELL EVERETT HWY
Manufacturer CityBOTHELL WA 98041
Manufacturer CountryUS
Manufacturer Postal98041
Manufacturer Phone4254877199
Manufacturer G1PHILIPS MEDICAL SYSTEMS
Manufacturer StreetPO BOX 10.000 VEENPLUIS 4-6
Manufacturer CityBEST 5680DA
Manufacturer CountryNL
Manufacturer Postal Code5680 DA
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameINTEGRIS H3000
Generic NameIZF (SYSTEM, XRAY, TOMOGRAPHIC)
Product CodeIZF
Date Received2010-11-17
Model Number72238
Catalog NumberNA
Lot NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerPHILIPS MEDICAL SYSTEMS
Manufacturer AddressPO BOX 10.000 VEENPLUIS 4-6 BEST 5680DA NL 5680 DA


Patients

Patient NumberTreatmentOutcomeDate
10 2010-11-17

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