MAUDE Adverse Event Report: GE HEALTHCARE PROTEUS XR; X-RAY MACHINE

Model Number 531995

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/19/2016

Event Type  malfunction  

Event Description

Vertical bucky has exposure hold that will not allow the room to expose for lateral chests or lateral c-spines.

• Brand Name: PROTEUS XR
• Type of Device: X-RAY MACHINE
• Manufacturer (Section D): GE HEALTHCARE; waukesha WI
• MDR Report Key: 6232422
• MDR Text Key: 64343710
• Report Number: MW5067089
• Device Sequence Number: 1
• Product Code: KPR
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 531995
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/30/2016
• Type of Device Usage: N
• Patient Sequence Number: 1