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

Device Problem Insufficient Information (3190)

Patient Problem No Patient Involvement (2645)

Event Date 08/17/2016

Event Type  Injury  

Manufacturer Narrative

Ge healthcare's investigation is ongoing.A follow-up report will be submitted once the investigation has been completed.Device evaluation anticipated, but not yet begun.

Event Description

On (b)(6) 2016, the gehc employee reported that as they were performing replacement of the longitudinal locks on a proteus radiographic device overhead tube suspension (ots), the employees fingers were caught in the clearance between ots rail and the ceiling which resulted in a cut to two fingers on their right hand.Per the judgment of the treating clinician, sutures were applied to treat the wound.

Manufacturer Narrative

Upon completion of replacement of the longitudinal lock, the ge field engineer (fe) identified an abnormal noise coming from the longitudinal lock assembly.In order to investigate this abnormal noise, the fe placed one hand between the lock mechanism and the ceiling of the exam room for support, and with his other hand he physically moved the overhead tube suspension (ots) bridge longitudinally, while a second fe was pressing the lock release buttons on the ots uif console.As the fe physically moved the ots bridge, his fingers were pinched between the ots bridge and the ceiling which caused the finger laceration.Ge healthcare's investigation has completed and it was determined the service personnel did not check the functionality of the longitudinal locks per the instructions provided in the ots service manual.As a correction, the fe was made aware to follow the ots service manual when checking the functionality of the ots locks.

• 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., LTD.; no.1, yong chang north rd.; beijing econ.&tech.dev.zone; beijing 10017 6; CH 100176
• Manufacturer Contact: steven walczak ; 3000 north grandview blvd.; waukesha, WI 53188-1696
• MDR Report Key: 5954974
• MDR Text Key: 54879485
• Report Number: 9613445-2016-00003
• 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: other
• Type of Report: Initial,Followup
• Report Date: 08/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2016
• 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: 10/07/2016
• 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
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 44 YR
• Patient Weight: 70