MAUDE Adverse Event Report: GE MEDICAL SYSTEMS, LLC PRECISION 500D; SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED

Model Number XRF117

Device Problems Detachment Of Device Component (1104); Component Falling (1105)

Patient Problem Head Injury (1879)

Event Date 04/06/2015

Event Type  malfunction  

Event Description

It was reported that as the user was moving the suspended dual lcd monitors from a precision 500d x-ray system, the monitors detached from the monitor suspension and fell approximately one to one and a half feet before striking the technologist on the head.The technologist did not receive an injury as a result of this event and the monitor's cables prevented the monitors from falling to the floor.

Manufacturer Narrative

No report of patient involvement.Ge healthcare's investigation is ongoing.A follow up report will be submitted once the investigation has been completed.

Manufacturer Narrative

Ge healthcare's investigation is completed and the root cause of this monitor detachment was due to a design issue of insufficient thread engagement due to a shorter screw length which led to internal thread stripping in the brake barrel.The budapest monitor suspension installed on this system was obsoleted in 2009 and therefore is not a field replaceable unit (fru).As an immediate correction, a new (b)(4) lcd monitor suspension was installed at the site to correct the issue.This action has also been reported to the fda per 21 cfr part 806 on 06/24/2015, please reference corrections and removals report number 2126677-06/24/15-008-(b)(4).

• Brand Name: PRECISION 500D
• Type of Device: SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED
• Manufacturer (Section D): GE MEDICAL SYSTEMS, LLC; 3000 n.grandview blvd.; w450; waukesha WI 53188
• Manufacturer (Section G): GE MEDICAL SYSTEMS, LLC; 3000 n.grandview blvd.; w450; waukesha WI 53188
• Manufacturer Contact: paul corrigan ; 3000 n.grandview blvd.; w450; waukesha, WI 53188 ; 4142130021
• MDR Report Key: 4743910
• MDR Text Key: 5887570
• Report Number: 2126677-2015-00008
• Device Sequence Number: 1
• Product Code: JAA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081091
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 04/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: XRF117
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/06/2015
• Initial Date FDA Received: 05/01/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/22/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/12/2002
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: 2126677-06/24/15-008-C
• Patient Sequence Number: 1