MAUDE Adverse Event Report: HANGWEI(BEIJING)GE HANGWEI MEDICAL SYSTEMS CO.,LTD PROTEUS XR/A; SYSTEM, X-RAY, STATIONARY

Device Problem Component Falling (1105)

Patient Problem No Patient Involvement (2645)

Event Date 07/10/2015

Event Type  malfunction  

Manufacturer Narrative

Ge healthcare's investigation is ongoing.A follow-up report will be submitted once the investigation has been completed.The initial reporter is located outside the u.S., and therefore this information is not provided due to country privacy laws.

Event Description

It was reported that, during de-installation of the proteus xr/a x-ray system, a ceiling rail fell from the ceiling as one field engineer was taking a bolt out of the ceiling rail that holds the overhead tube suspension.The rail contacted a second field engineer who was standing beneath the rail.No injury was reported as a result of this event.

Manufacturer Narrative

Ge healthcare investigation concluded the installer did not properly position the hoist below the stationary rail during de-installation.Training was provided with the installer on the correct process for de-installation of the overhead railings.No further actions are required at this time.

• Brand Name: PROTEUS XR/A
• Type of Device: SYSTEM, X-RAY, STATIONARY
• Manufacturer (Section D): HANGWEI(BEIJING)GE HANGWEI MEDICAL SYSTEMS CO.,LTD; no.1, yong chang north rd.; beijing econ.&tech.dev.zone; beijing 10017 6; CH 100176
• Manufacturer (Section G): HANGWEI (BEIJING) GE HANGWEI MEDICAL SYSTEMS CO.,; no.1, yong chang north rd.; beijing econ.&tech.dev.zone; beijing 10017 6; CH 100176
• Manufacturer Contact: john szalinski ; 540 w. northwest highway; barrington, IL 60010-3076
• MDR Report Key: 4973021
• MDR Text Key: 23681153
• Report Number: 9613445-2015-00006
• Device Sequence Number: 1
• Product Code: KPR
• Combination Product (y/n): N
• PMA/PMN Number: K993090
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Followup
• Report Date: 07/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/05/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/1970
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1