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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Injury (2348)

Event Date 07/15/2014

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that during the course of unplanned service of the device, the ge healthcare field service engineer sustained a lower back sprain as a result of the repetitive lifting required to perform the service.Toradol was administered intramuscularly as treatment for pain and inflammation.

• Brand Name: OPTIMA XR220
• Type of Device: MOBILE X-RAY SYSTEM
• Manufacturer (Section D): GE MEDICAL SYSTEMS, LLC; waukesha WI
• Manufacturer (Section G): GE MEDICAL SYSTEMS, LLC; waukesha WI
• Manufacturer Contact: james giles ; 3000 n grandview blvd.; waukesha, WI 53188 ; 2625482089
• MDR Report Key: 4023916
• MDR Text Key: 19400409
• Report Number: 2126677-2014-00014
• Device Sequence Number: 1
• Product Code: IZL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103476
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 07/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/15/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other