MAUDE Adverse Event Report: GE HEALTHCARE GAMMA CAMERA

Model Number INFINIA HAWKEYE

Device Problem Device Tipped Over (2589)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/14/2014

Event Type  Injury  

Event Description

On (b)(6) 2014, a pt was lifted off of the ge infinia hawkeye table onto a gurney and wheeled out of the room.The tech pushed the "unload" button to set the table up for the next pt and walked out of the room.When the table was fully lowered, it tipped over and fell over its side.A staff member said that he saw the table fall over slowly and there was no objects around the table.There was no pt or staff injuries.

• Brand Name: GAMMA CAMERA
• Type of Device: GAMMA CAMERA
• Manufacturer (Section D): GE HEALTHCARE
• MDR Report Key: 3775725
• MDR Text Key: 20454448
• Report Number: MW5035783
• Device Sequence Number: 1
• Product Code: IYX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/21/2014

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: Health Professional
• Device Model Number: INFINIA HAWKEYE
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/22/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention