MAUDE Adverse Event Report: GE HANGWEI MEDICAL SYSTEMS CO., LTD. DISCOVERY XR656; SYSTEM, X-RAY, TOMOGRAPHIC

Device Problems Loose or Intermittent Connection (1371); Device Operates Differently Than Expected (2913)

Patient Problems Bone Fracture(s) (1870); Laceration(s) (1946)

Event Date 05/29/2015

Event Type  Injury  

Event Description

It was reported that during installation of the discovery xr656 wall stand, it was identified that the counterweights within the wall stand column were not moving up and down as the detector arm was moved.At that time, the vendor field engineer (fe) removed the wall stand top cover to check the counterweights and identified the belt that is responsible for lifting the counterweights was loose.As the fe was troubleshooting this event, the fe put their hand under the suspended counterweights when the counterweights suddenly fell and impacted the field engineer's finger.The field engineer received a fracture and laceration on their left ring finger.The treatment that was completed was to clean and suture the wound.

Manufacturer Narrative

The initial reporter is located outside the u.S., and therefore this information is not provided due to country privacy laws.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 has concluded and the cause of this event was determined to be an installation error as the installer should never position their hands directly under the counterweights during servicing or installation of this device.

• Brand Name: DISCOVERY XR656
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHIC
• Manufacturer (Section D): GE HANGWEI MEDICAL SYSTEMS CO., LTD.; no. 2 yong chang north rd.; beijing, 10017 6; CH 100176
• Manufacturer (Section G): GE HANGWEI MEDICAL SYSTEMS CO., LTD.; no. 2 yong chang north rd.; beijing, 10017 6; CH 100176
• Manufacturer Contact: john szalinski ; 540 w. northwest highway; barrington, IL 60010-3076 ; 8472774719
• MDR Report Key: 4871752
• MDR Text Key: 6047009
• Report Number: 9613445-2015-00005
• Device Sequence Number: 1
• Product Code: IZF
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K132261
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/19/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/20/2014
• 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 Outcome(s): Other
• Patient Age: 25 YR
• Patient Weight: 60