PHILIPS X-RAY

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-05-21 for PHILIPS X-RAY manufactured by .

Event Text Entries

[21050208] The main (b)(4) x-ray display in lab 3 had a major failure with the mounting system. When i arrived in lab 3, the display was lying on the floor. The drive mechanism for the display to go up and down consists of 2 square pipes with a bolt inside the pipes and a motor that drives a gear up and down the bolt. The bolt looked like it did not have any damage to it. The treads on the bolt looked fine. It seemed like the failure was with the drive gear portion of the mechanism. Unfortunately the motor and drive gear part are inside the second pipe where you could not see it very well. So we could not determine for sure what failed w/o taking the drive mechanism out of the square tube. Dms removed the display and mounting parts so we will have to find out from them what they found when it was taken apart. Also there did not seem to be a fail safe in place that would prevent the display from falling all the way to the floor if the drive mechanism failed like ours did.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report Number	MW5030299
MDR Report Key	3135332
Date Received	2013-05-21
Date of Report	2013-05-10
Date of Event	2013-05-08
Date Added to Maude	2013-05-30
Event Key	0
Report Source Code	Voluntary report
Manufacturer Link	N
Number of Patients in Event	0
Adverse Event Flag	3
Product Problem Flag	3
Reprocessed and Reused Flag	0
Reporter Occupation	RISK MANAGER
Health Professional	3
Initial Report to FDA	3
Report to FDA	0
Event Location	0
Single Use	0
Previous Use Code	0
Event Type	3
Type of Report	3

Device Details

Brand Name	PHILIPS X-RAY
Generic Name	NONE
Product Code	IZO
Date Received	2013-05-21
Device Availability	N
Device Sequence No	1
Device Event Key	0

Patients

Patient Number	Treatment	Outcome	Date
1	0		2013-05-21