MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS ALLURA XPER FD20/10; SYSTEM, X-RAY ANGIOGRAPHIC

Device Problems Sticking (1597); Device Inoperable (1663)

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

Event Date 07/01/2016

Event Type  malfunction  

Event Description

Drape got sucked into housing by tooth causing the c-arm to lock and become immovable.

• Brand Name: ALLURA XPER FD20/10
• Type of Device: SYSTEM, X-RAY ANGIOGRAPHIC
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 595 miner road; cleveland, OH 44143
• MDR Report Key: 5916982
• MDR Text Key: 53626791
• Report Number: 5916982
• Device Sequence Number: 1
• Product Code: IZI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/02/2016,08/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/02/2016
• Device Age: 8 YR
• Event Location: Hospital
• Date Report to Manufacturer: 08/02/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 90 YR