MAUDE Adverse Event Report: PHILIPS ALLURA XPER FD; CARDIOVASCULAR SYSTEM IN CARDIAC CATH LAB

Model Number ALLURA XPER FD20

Device Problem Computer Operating System Problem (2898)

Patient Problem No Patient Involvement (2645)

Event Date 04/10/2020

Event Type  malfunction  

Event Description

Cath lab (cardiac catheterization lab) would not boot up at start of the day.Failure of the ippc (image processing pc).This device has failed on (b)(6) 2019 and (b)(6) 2020 as well.[manufacturer] can only replace the part which then fails and then several months later it fails again.This time there was not a patient on the table yet.Manufacturer response for cardiovascular system in cardiac cath lab, philips allura xper fd 20 (per site reporter).Keep replacing the part (which then fails in a few months).

• Brand Name: ALLURA XPER FD
• Type of Device: CARDIOVASCULAR SYSTEM IN CARDIAC CATH LAB
• Manufacturer (Section D): PHILIPS; 3721 valley centre drive, suite 500; san diego CA 92121
• MDR Report Key: 9995253
• MDR Text Key: 188838768
• Report Number: 9995253
• Device Sequence Number: 1
• Product Code: OWB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: ALLURA XPER FD20
• Device Catalogue Number: 772006
• 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: 04/21/2020
• Device Age: 6 YR
• Event Location: Hospital
• Date Report to Manufacturer: 04/24/2020
• Type of Device Usage: N
• Patient Sequence Number: 1