MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. ALLURA XPER FD 20; SYSTEM, X-RAY, ANGIOGRAPHIC

Model Number FD20

Device Problem Unexpected Shutdown (4019)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/04/2021

Event Type  malfunction  

Event Description

Phillips allura xper fd 20 shut down in the middle of the procedure needing to be rebooted.This cause a delay in the procedure, no harm occurred to the patient.Manufacturer response for allura xper fd 20 x-ray device, allura xper fd 20 (per site reporter).Currently being evaluated by philips.

• Brand Name: ALLURA XPER FD 20
• Type of Device: SYSTEM, X-RAY, ANGIOGRAPHIC
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; 3721 valley centre drive, suite 500; san diego CA 92130
• MDR Report Key: 12512163
• MDR Text Key: 272693466
• Report Number: 12512163
• Device Sequence Number: 1
• Product Code: IZI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/10/2021

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: FD20
• Device Catalogue Number: 1168-13159
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/10/2021
• Device Age: 8 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/22/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 19345 DA
• Patient Weight: 64