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

Model Number FD20

Device Problems Entrapment of Device (1212); Mechanical Jam (2983)

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

Event Date 12/16/2016

Event Type  malfunction  

Event Description

Pt on the table for peripheral procedure.After start of case, the sterile drape got sucked into housing by tooth, causing the c-arm to lock and become immovable in image detector and making it unable to rotate camera around patient.Fortunately, case was a peripheral case, and rotation was not needed.

• Brand Name: ALLURA XPER
• Type of Device: SYSTEM, X-RAY, ANGIOGRAPHIC
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 595 miner rd.; cleveland OH 44143
• MDR Report Key: 6299923
• MDR Text Key: 66463171
• Report Number: 6299923
• 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: 01/10/2017

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: No Information
• Device Model Number: FD20
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/10/2017
• Event Location: Hospital
• Date Report to Manufacturer: 01/10/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/03/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 67 YR