MAUDE Adverse Event Report: GE HANGWEI MEDICAL SYSTEMS CO., LTD. OPTIMA XR646; SYSTEM, X-RAY, STATIONARY

Device Problems Use of Device Problem (1670); Unintended Movement (3026)

Patient Problems Crushing Injury (1797); Injury (2348)

Event Date 01/15/2021

Event Type  Injury  

Manufacturer Narrative

Ge healthcare¿¿s investigation into the reported event has been initiated and is ongoing.A follow-up report will be submitted when the investigation has been completed.Device evaluation anticipated, but not yet begun.

Event Description

On (b)(6) 2021, during the installation of an optima xr646 fixed radiographic x-ray system at the (b)(6) hospital in (b)(6), the ge field service engineer (fe) reported they were injured while performing wall stand alignment calibrations.The fe stated they had placed their right hand on the wall stand column and their left hand was used to move the wall stand down toward the floor.The wall stand column covers were removed at the time of this event.As the wall stand moved down, the counterweight in the column moved up and pinched their finger between a section of the column and the counterweight resulting in a crushing injury to the fingertip that was treated with sutures.This is considered a serious injury.

Manufacturer Narrative

Ge healthcare's investigation has been completed and the cause of the injury to the ge field engineer (fe) was a servicing error.During the wall stand calibration process, the fe unintentionally placed his finger in a hole on the column.The holes on the column are used to insert bolts to secure the counterweights during shipment and servicing events and are not accessible during clinical use.There is a caution note and symbol within the in service manual warning the service representative to the potential finger pinch danger while servicing the counterweights.The fe should have ensured his finger was clear of danger prior to adjusting the wall stand.As a correction for this incident, retraining was made with the fe reminding them of the caution in the service documentation.No further actions are needed.

• Brand Name: OPTIMA XR646
• Type of Device: SYSTEM, X-RAY, STATIONARY
• Manufacturer (Section D): GE HANGWEI MEDICAL SYSTEMS CO., LTD.; west area of building no.3,; no.1 yongchang north road; beijing 10017 6; CH 100176
• MDR Report Key: 11214569
• MDR Text Key: 228189051
• Report Number: 9613445-2021-00001
• Device Sequence Number: 1
• Product Code: KPR
• Combination Product (y/n): N
• PMA/PMN Number: K143270
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 35 YR
• Patient Weight: 65