CLINIXE SYSTEM 70438

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2012-08-01 for CLINIXE SYSTEM 70438 manufactured by Philips Medical Systems (cleveland), Inc..

Event Text Entries

[17977734] The customer states the wall bucky tray is able to be pulled out. The field service engineer (fse) went to the site and confirmed that the screws that retain the catch component of the wall bucky system were sheared off. This resulted in the bucky tray being able to be pulled out of the bucky system by the user. The wall bucky system screws were replaced and secured with loctite. The bucky tray can no longer be pulled entirely out of the wall bucky system. There was no report of death or serious injury.
Patient Sequence No: 1, Text Type: D, B5


[18174395] Note: we have not completed our investigation of this event. We will file a f/u mdr at the completion of the investigation. (b)(4).
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1525965-2012-00044
MDR Report Key2685274
Report Source06
Date Received2012-08-01
Date of Report2012-05-11
Date Mfgr Received2012-05-11
Date Added to Maude2012-11-23
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactKUMUDINI CARTER
Manufacturer Street595 MINER RD.
Manufacturer CityCLEVELAND OH 44143
Manufacturer CountryUS
Manufacturer Postal44143
Manufacturer Phone4404833032
Single Use0
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCLINIXE SYSTEM
Product CodeIZF
Date Received2012-08-01
Model Number70438
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerPHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.
Manufacturer Address595 MINER RD. CLEVELAND OH 44143 US 44143


Patients

Patient NumberTreatmentOutcomeDate
10 2012-08-01

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