MAUDE Adverse Event Report: WSO GE MEDICAL SYSTEMS, LLC DEFINIUM 8000; STATIONARY X-RAY SYSTEM

Lot Number 100172WG6

Device Problems Component Falling (1105); Mechanical Problem (1384); Unintended Movement (3026)

Patient Problem Bone Fracture(s) (1870)

Event Date 05/27/2016

Event Type  Injury  

Manufacturer Narrative

Ge healthcare's investigation is ongoing.A follow-up report will be submitted once the investigation has been completed.Attempts to collect this information are being completed with the user facility.Device evaluated by user facility.Date of device manufacture is currently unknown as the device system identification number was not provided.Ge healthcare's investigation is ongoing.A follow-up report will be submitted once the investigation has been completed.Attempts to collect this information are being completed with the user facility.Device evaluated by user facility.Date of device manufacture is currently unknown as the device system identification number was not provided.

Event Description

During a lateral chest x-ray at the wall stand, the patient positioned their hands on the lateral support bar.At that time, the detector moved to a -2 degree position, so in order to move the detector into an upright position where it would shoot that image, the employee asked the patient to move just a little bit, grabbed the release bar and braced it with the employee's right hand as what's normally done to move it back into a 0 degree placement.At that time, the detector moved forward and the lateral bar came down on the patient's head, and the employee caught the brunt of the forward motion on the employee's arm.There was no injury to the patient, but the employee's shoulder is now hurt and is being seen by employee health.The employee was later diagnosed with a fractured clavicle.

Manufacturer Narrative

Ge healthcare¿s investigation has completed and the cause of this event was identified as a combination of hardware wear and user error.All service activities for this site are completed by in-house biomedical engineers.Upon communication with the in-house biomed team, it was determined the wall stand gas spring was worn causing the wall stand to tilt faster than expected when the locks were released.The gas spring was requested to be returned to ge healthcare but the in-house biomed team confirmed they discarded all parts.They did confirm they replaced the gas spring to correct the issue.In addition, the user was also made aware to remove the lateral bar and clear patients from the wall stand when conducting the tilting operation as stated in the operator¿s manual.No further actions are required.Corrected data: upon further follow up with the user for additional details regarding this incident, it was discovered the original injury that occurred was incorrectly reported.The original information received by the user stated the technologist was diagnosed with a right clavicle fracture and tendonitis of two main muscles when in fact the er diagnosis report was confirmed as an ¿unspecified soft tissue right shoulder and upper arm injury treated with ice application¿ which is considered minor.Device evaluated by user's in-house biomedical engineer.Ge healthcare¿s investigation has completed and the cause of this event was identified as a combination of hardware wear and user error.All service activities for this site are completed by in-house biomedical engineers.Upon communication with the in-house biomed team, it was determined the wall stand gas spring was worn causing the wall stand to tilt faster than expected when the locks were released.The gas spring was requested to be returned to ge healthcare but the in-house biomed team confirmed they discarded all parts.They did confirm they replaced the gas spring to correct the issue.In addition, the user was also made aware to remove the lateral bar and clear patients from the wall stand when conducting the tilting operation as stated in the operator¿s manual.No further actions are required.Corrected data: upon further follow up with the user for additional details regarding this incident, it was discovered the original injury that occurred was incorrectly reported.The original information received by the user stated the technologist was diagnosed with a right clavicle fracture and tendonitis of two main muscles when in fact the er diagnosis report was confirmed as an ¿unspecified soft tissue right shoulder and upper arm injury treated with ice application¿ which is considered minor.

• Brand Name: DEFINIUM 8000
• Type of Device: STATIONARY X-RAY SYSTEM
• Manufacturer (Section D): WSO GE MEDICAL SYSTEMS, LLC; 3000 n grandview blvd.; waukesha WI 53188
• Manufacturer (Section G): WSO GE MEDICAL SYSTEMS, LLC; 3000 n grandview blvd.; waukesha WI 53188
• Manufacturer Contact: steven walczak ; 3000 north grandview blvd.; waukesha, WI 53188-1696
• MDR Report Key: 6023361
• MDR Text Key: 57184317
• Report Number: 2126677-2016-00015
• Device Sequence Number: 1
• Product Code: KPR
• Combination Product (y/n): N
• PMA/PMN Number: K051967
• 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: 09/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: 100172WG6
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/01/2016
• 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: 63 YR