MAUDE Adverse Event Report: PHILLIPS MEDICAL SYSTEMS ALLURA XPER FD 20; SYSTEM, X-RAY, ANGIOGRAPHIC

Device Problem Device Inoperable (1663)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

Lost ability to manipulate bed.Manufacturer called and field service rep sent.Troubleshoot: ordered table interface module - did not fix problem.Ordered three additional parts: motor, table power supply and daughter board.Found bad fuse in motor, replaced motor and power supply; power supply took out fuse in motor.Table put back in service.

• Brand Name: ALLURA XPER FD 20
• Type of Device: SYSTEM, X-RAY, ANGIOGRAPHIC
• Manufacturer (Section D): PHILLIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• MDR Report Key: 4137599
• MDR Text Key: 4796663
• Report Number: 4137599
• Device Sequence Number: 1
• Product Code: IZI
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 09/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/26/2014
• Device Age: 3 YR
• Event Location: Hospital
• Date Report to Manufacturer: 10/03/2014
• Patient Sequence Number: 1