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

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

Patient Problem Bone Fracture(s) (1870)

Event Date 07/20/2018

Event Type  Injury  

Manufacturer Narrative

A ge healthcare investigation has been initiated and is ongoing.A follow-up mdr will be provided when ge healthcare's investigation has been completed.Although requested by ge healthcare, the customer was unable to provide the injured person's demographics.Device evaluation anticipated, but not yet begun.

Event Description

On (b)(6) 2018, the technologist at (b)(6) in the united states reported that while positioning a heavy patient to the center of the table to perform a left side lateral l-spine exam on their proteus system on (b)(6) 2018, they were pushing the patient toward the center of the table with one of their hands placed at each of the patient¿s shoulders and the table suddenly moved laterally.The technologist stated the force of this table movement caused her left hand fifth digit to contact the patient abruptly and become injured.The technologist splinted the finger and received an x-ray two days later which was diagnosed as a possible left hand fifth metacarpal fracture.The technologist then had a second opinion from an orthopedic doctor who reviewed the x-rays and confirmed it was a fracture of the left hand fifth metacarpal.

Manufacturer Narrative

Ge healthcare's investigation has been completed and the cause for the finger injury could not be determined.The ge field engineer (fe) arrived at the site for troubleshooting and reproduced the table top moved in the lateral direction when an unknown amount of force was applied to it.Ge design specification of the force needed to move the table in a locked position is 150n.The fe returned to the site to measure the force to move the table and the result was approximately 200n.During additional investigation by the ge engineering team, a similar proteus table was tested to confirm the force values needed to move the table top in a lock state.Testing showed that for a person weighing 64.5kg, the pushing force reaches approximately 175n to move the table top.Additional tests were performed where increments of oil were added to the brake rods with a 100kg weight applied to the table which all resulted in a force of greater than 500n to move the tabletop.Although the root cause for the technologist finger injury is undetermined, the most probable root cause is use error due to the technologists pushing a large patient with high force as the foot side technologist was leaning their body into the table top.If the foot end technologist overcame the brake force, this resulted in sudden motion resulting in the shoulder side technologist losing their balance contributing to the injury if the fingers were in an awkward position.A correction was recommended by reminding the user to be mindful of the amount of force applied to the tabletop when positioning patients, but the customer wanted no further communication related to this event.No further actions are needed.

• Brand Name: PROTEUS
• 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: 7728241
• MDR Text Key: 115348076
• Report Number: 9613445-2018-00002
• 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
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 10/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 07/23/2018
• Initial Date FDA Received: 07/27/2018
• Supplement Dates Manufacturer Received: 10/11/2018
• Supplement Dates FDA Received: 10/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention