MAUDE Adverse Event Report: WSO GE MEDICAL SYSTEMS, LLC AMX 4; SYSTEM, X-RAY MOBILE

Device Problems Use of Device Problem (1670); Insufficient Information (3190)

Patient Problems Fall (1848); Bone Fracture(s) (1870)

Event Date 05/17/2017

Event Type  Injury  

Manufacturer Narrative

Due to country specific privacy laws, patient information is not available.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) 2017, the technologist at hospital (b)(6) reported they were injured while driving their amx 4 mobile system exiting an elevator.The technologist did not notice the floor of the elevator was lower than the hallway floor and as they were walking backward driving the system out from the elevator, their foot impacted the ingress to the hallway and they accidently drove the mobile device into their ankle and fell to the ground.The technologist was diagnosed with a fractured ankle that required surgery.

Manufacturer Narrative

Ge healthcare¿s investigation has completed and the cause of this event was identified as a use error as the operator was not using their clinical experience and judgment when transporting a mobile device through the hospital which includes checking for uneven surfaces, objects and people when attempting to safely maneuver the mobile system throughout the hospital.A ge field engineer did visit the site and confirmed there was no malfunction on the mobile device.No further actions are needed.

• Brand Name: AMX 4
• Type of Device: SYSTEM, X-RAY MOBILE
• Manufacturer (Section D): WSO GE MEDICAL SYSTEMS, LLC; 3000 north grandview blvd.; waukesha WI
• Manufacturer Contact: anne krueger ; 3000 north grandview boulevard; waukesha, WI
• MDR Report Key: 6599641
• MDR Text Key: 76235511
• Report Number: 2126677-2017-00008
• Device Sequence Number: 1
• Product Code: IZL
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K802047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 07/18/2017

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: No Information
• Other Device ID Number: UDI NOT REQUIRED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/17/2017
• Initial Date FDA Received: 05/30/2017
• Supplement Dates Manufacturer Received: 07/12/2017
• Supplement Dates FDA Received: 07/18/2017
• 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): Other