MAUDE Adverse Event Report: PHILLIPS, NEDERLAND B.V. PHILLIPS; C-ARM

Model Number INTEGRIS

Device Problem Unintended Movement (3026)

Patient Problems Fall (1848); Injury (2348)

Event Date 10/02/2014

Event Type  Injury  

Event Description

Pt transferred to ir table for procedure.During transfer process and while 4 staff were in close proximity, the ir table "kicked" out and pt fell head first onto floor.An employee was also injured.There was no mechanism to lock the table to prevent it from moving during the process of transferring pt to and from the table.

• Brand Name: PHILLIPS
• Type of Device: C-ARM
• Manufacturer (Section D): PHILLIPS, NEDERLAND B.V.; nederland b.v.
• MDR Report Key: 4341364
• MDR Text Key: 5172912
• Report Number: MW5039606
• Device Sequence Number: 1
• Product Code: IZI
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/11/2014

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: INTEGRIS
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/11/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention