MAUDE Adverse Event Report: GE HANGWEI MEDICAL SYSTEMS CO. [RPTEIS XR/A; SYSTEM, X-RAY, STATIONARY

Model Number XRA560

Device Problem Detachment Of Device Component (1104)

Patient Problems Contusion (1787); Injury (2348)

Event Date 07/18/2014

Event Type  malfunction  

Event Description

It was reported that when the technologist was rotating the collimator of a proteus xr/a x-ray system for pt positioning, the collimator detached and impacted the pt's elbow resulting in a minor contusion.An x-ray was completed on the pt's elbow and the x-rays were negative.

Manufacturer Narrative

Pt weight was not provided.Ge healthcare's investigation is ongoing.A follow up report will be submitted once the investigation has been completed.

• Brand Name: [RPTEIS XR/A
• Type of Device: SYSTEM, X-RAY, STATIONARY
• Manufacturer (Section D): GE HANGWEI MEDICAL SYSTEMS CO.; beijing ; CH
• Manufacturer (Section G): GE HANGWEI MEDICAL SYSTEMS CO., LTD.; beijing ; CH
• Manufacturer Contact: paul corrigan ; 3000 n grandview blvd; waukesha, WI 53188 ; 4142130021
• MDR Report Key: 4173502
• MDR Text Key: 5091338
• Report Number: 9613445-2014-00107
• Device Sequence Number: 1
• Product Code: KPR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K993090
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: XRA560
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/12/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/01/2006
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 4 YR