MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. PHILIPS ALLURA XPER FD20; SYSTEM X-RAY ANGIOGRAPH

Model Number 722012 ALLURA XPER

Device Problem Communication or Transmission Problem (2896)

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

Event Date 03/22/2019

Event Type  Injury  

Event Description

During a cardiac ablation procedure, the phillips allura xper fd20 x-ray malfunctioned and the image did not transmit to the cath lab monitor.The manufacturer was called and they were unable to complete the planned procedure.The sheaths were removed and the patient was recovered and discharged in stable conditions.

• Brand Name: PHILIPS ALLURA XPER FD20
• Type of Device: SYSTEM X-RAY ANGIOGRAPH
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
• MDR Report Key: 8906404
• MDR Text Key: 155180210
• Report Number: MW5089116
• 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: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial

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: 722012 ALLURA XPER
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/16/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR
• Patient Weight: 84