MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. ALLURA XPER FD10/10; INTERVENTIONAL FLOUROSCOPIC X-RAY SYSTEM

Model Number ALLURA XPER FD10/10

Device Problem Failure to Power Up (1476)

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

Event Date 04/25/2023

Event Type  malfunction  

Event Description

It has been reported to philips that the system failed to power on.The device was not in clinical use at the time of the event.No harm has been reported to philips.Philips has started an investigation of this complaint.

Manufacturer Narrative

Philips has investigated this complaint.A philips field service engineer (fse) inspected the system and confirmed that system could not be powered on.It was reported that at the end of examination there was a popping sound while the monitor and examination lights were being retracted, and the system did not turn on at all.Review of error log file revealed unsolicited power down.Fse assumed that it is likely due to a short circuit occurred in the operating light cable based on the sound and the condition of the operating light cable.The short circuit was thought to have tripped the breaker on the power supply that powers the operating light line, preventing the device from turning on.Further the spotlight that was the source of the failure was replaced by fse with the successor model, the led type.After replacement, the system was returned to use in good working order.The codes were updated based on the investigation outcome.Evaluation method code was corrected.

• Brand Name: ALLURA XPER FD10/10
• Type of Device: INTERVENTIONAL FLOUROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; veenpluis 6; best 5684 PC; NL 5684 PC
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; veenpluis 6; best 5684 PC; NL 5684 PC
• Manufacturer Contact: dusty leppert ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 16850839
• MDR Text Key: 314385360
• Report Number: 3003768277-2023-02621
• Device Sequence Number: 1
• Product Code: IZI
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K031333
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

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: ALLURA XPER FD10/10
• Device Catalogue Number: 722005
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/25/2023
• Initial Date FDA Received: 05/01/2023
• Supplement Dates Manufacturer Received: 08/31/2023
• Supplement Dates FDA Received: 09/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/05/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1