DIAGNOST 76 70639 NA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-09-09 for DIAGNOST 76 70639 NA manufactured by Philips Medizin Systeme.

Event Text Entries

[15207516] The cover which prevented the collimator from falling had missing screws.
Patient Sequence No: 1, Text Type: D, B5


[15658576] The cover screws were reinstalled and the collimator operated according to specifications.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number3003768251-2010-00024
MDR Report Key1839773
Report Source05
Date Received2010-09-09
Date of Report2009-07-20
Date Mfgr Received2009-07-20
Date Added to Maude2011-01-25
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 98021
Manufacturer CountryUS
Manufacturer Postal98021
Manufacturer Phone4254877199
Single Use3
Remedial ActionRP
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameDIAGNOST 76
Generic NameIXL (DEVICE, SPOT FILM)
Product CodeIXL
Date Received2010-09-09
Model Number70639
Catalog NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerPHILIPS MEDIZIN SYSTEME
Manufacturer AddressROENTGENSTR. 24 HAMBURG 22335 GM 22335


Patients

Patient NumberTreatmentOutcomeDate
10 2010-09-09

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