MAUDE Adverse Event Report: WSO GE MEDICAL SYSTEMS, LLC OPTIMA XR200; OPTIMA XR220 SYSTEM, X-RAY, MOBILE

Model Number 5555000-4

Device Problems Unintended Arm Motion (1033); Component Falling (1105)

Patient Problems Abrasion (1689); Skin Tears (2516)

Event Date 07/21/2016

Event Type  Injury  

Manufacturer Narrative

Ge healthcare's investigation is ongoing.A follow up report will be submitted once the investigation has been completed.

Event Description

On (b)(6) 2016, the user at (b)(6) reported that during a patient shoulder radiographic exam, after the technologist positioned and released the horizontal tube arm, the tube arm dropped impacting a patient.The patient received a skin tear above their right eye requiring three sutures in addition to a minor cut to their left hand.

Manufacturer Narrative

Ge healthcare's investigation has completed and the cause of the drifting horizontal tube arm was determined to be a sticking lock release button located on the collimator handle.During service evaluation of the system, the ge field engineer identified the hospital's in-house biomedical engineer applied tape to the lock release switch to cover a crack in the button.When the sticking lock release was reproduced, it was identified the tape caused a decreased clearance between the lock release switch and the collimator handle which in turn caused the locking handle to become jammed and stick in the unlocked position.To correct this issue, the ge field engineer replaced the collimator.The hospital was also made aware of the ge healthcare investigation conclusion.No further actions are required.

• Brand Name: OPTIMA XR200
• Type of Device: OPTIMA XR220 SYSTEM, X-RAY, MOBILE
• Manufacturer (Section D): WSO GE MEDICAL SYSTEMS, LLC; 3000 north grandview blvd.; waukesha WI 53188
• Manufacturer (Section G): WSO GE MEDICAL SYSTEMS, LLC; 3000 north grandview boulevard; waukesha WI 53188
• Manufacturer Contact: steven walczak ; 3000 north grandview boulevard; waukesha, WI 53188-1696
• MDR Report Key: 5885600
• MDR Text Key: 52406234
• Report Number: 2126677-2016-00012
• Device Sequence Number: 1
• Product Code: IZL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142383
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Radiologic Technologist
• Type of Report: Initial,Followup
• Report Date: 07/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 5555000-4
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/11/2016
• 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: 94 YR
• Patient Weight: 52