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

Model Number XRA590

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Bone Fracture(s) (1870)

Event Date 12/04/2015

Event Type  Injury  

Manufacturer Narrative

Ge healthcare¿s investigation into the reported occurrence is still ongoing.A follow-up report will be issued when the investigation has been completed.Device evaluation anticipated, but not yet begun.

Event Description

It was reported by the user, a radiology technologist broke her left distal finger while positioning the table during an exam.As the technologist pushed the table laterally away from herself, her hand was caught between the table top and the emergency stop button cover.A finger brace is being used to treat the broken finger.

Manufacturer Narrative

Ge healthcare¿s investigation concluded the root cause to be use error as the technologist placed their fingers underneath the table top during table positioning despite clear labeling instructions.The field engineer reminded the user to ensure they keep their hands clear during table top movements.Ge healthcare¿s investigation concluded the root cause to be use error as the technologist placed their fingers underneath the table top during table positioning despite clear labeling instructions.The field engineer reminded the user to ensure they keep their hands clear during table top movements.

• 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: john szalinski ; 540 w. northwest highway; barrngton, IL 60010
• MDR Report Key: 5323997
• MDR Text Key: 34263107
• Report Number: 2126677-2015-00032
• Device Sequence Number: 1
• Product Code: KPR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051967
• 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: 02/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: XRA590
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/15/2016
• 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: 60 YR
• Patient Weight: 64