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

Model Number ALLURA XPER FD20 OR TABLE

Device Problems No Apparent Adverse Event (3189); Activation Failure (3270)

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

Event Date 10/11/2023

Event Type  malfunction  

Event Description

It has been reported to the philips that the control computer did not turn on.There was no harm reported.Due to the lack of information, we are conservatively reporting this event.Philips has started an investigation of this complaint.

Manufacturer Narrative

Philips has investigated this complaint.This complaint was received on the allura system and alleged that the control computer did not turn on.At the time the complaint was received, philips did not have enough information to assess the impact of this issue on the live x-ray imaging functionality of the system and on the clinical procedure.Since at the time it was not possible to determine whether the issue would likely cause or contribute to death or serious injury upon recurrence, the complaint was conservatively reported.After investigation, philips has identified that the issue did not occur on the allura system but on the xper flex cardio monitoring equipment.The available information does not suggest that the malfunction would be difficult to detect since the failure of the device to power up would be evident to the user.Medical professionals will identify the problem and will either postpone procedures or utilize alternate monitoring equipment if warranted (which is specified/recommended in our labeling).As per the definition of non-reportable, this device/product issue did not cause or contribute to death or serious injury nor would likely cause or contribute to death or serious injury upon recurrence.After re-evaluation, as per non-reportable rationale device-hemo-55, philips concludes that this complaint is not reportable.The codes were updated based on investigation outcome.The device problem code was corrected.

• Brand Name: ALLURA XPER FD
• Type of Device: INTERVENTIONAL FLUOROSCOPIC 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: 17995337
• MDR Text Key: 326377927
• Report Number: 3003768277-2023-05784
• Device Sequence Number: 1
• Product Code: OWB
• UDI-Device Identifier: 00884838054240
• UDI-Public: 00884838054240
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K033737
• 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

• Date FDA Received: 10/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ALLURA XPER FD20 OR TABLE
• Device Catalogue Number: 722035
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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