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

Model Number ALLURA XPER FD20

Device Problem Activation Failure (3270)

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

Event Date 12/07/2023

Event Type  malfunction  

Event Description

It was reported to philips that equipment was not able to start.A trolley was stuck under the table, which was removed, however the equipment was still not able to start.No harm to the patient or user was reported.Philips has started an investigation of the complaint.

Manufacturer Narrative

Philips has investigated this complaint.When the customer arrived at the room and found that the system was not starting, and some cloth was stuck ed in the rails.To resolve the issue, customer removed the cloth and restarted the system.The field service engineer (fse) inspected the system onsite and found no problem.After restart, the system was returned to use in good working order.At the time this complaint was received, philips did not have enough information to exclude the potential for death or serious injury on recurrence, and as such the complaint was reported.Since that time, new information has been received which has led to the determination that this is scenario is not likely to cause or contribute to death or serious injury if it were to recur.This reported problem code combination and specific scenario was assessed by a post-market surveillance clinical expert and the assessment is as follows: certain procedures listed in the intended use above are used to prevent death and permanent impairment of the patient, for example in the cases of heart attack and stroke.The time it takes to clear a vessel occlusion is critical in these cases and to the outcome of the patient.Standard clinical practice/workflows dictate that an examination room be fully prepared prior to bringing a patient to the exam room for a procedure, including emergent procedures.This practice would include ensuring that the igts system is ready/powered on.There may be instances in which the system fails to power on as expected despite following the appropriate steps as outline in the ifu.There may be any number of reasons for failure of the system to power on prior to starting a procedure.The ifu recommends performing a cold restart (switching power off and then on again) every day to keep system quality at an acceptable level.Performing a cold restart is likely to restore system functionality, thus allowing the patient to be brought to the room for the procedure to proceed.A situation in which the system will not turn on as expected, but the issue is then resolved by utilizing the design mitigations provided by the device (warm restart or cold restart) is not likely to cause or contribute to death or serious injury if it were to recur.Based on the investigation results, philips concluded that the complaint is not reportable.The codes were updated based on the investigation outcome.

• Brand Name: ALLURA XPER FD
• Type of Device: SYSTEM, X-RAY, ANGIOGRAPHIC
• 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: derrick massuri ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 18419430
• MDR Text Key: 331614471
• Report Number: 3003768277-2023-07272
• Device Sequence Number: 1
• Product Code: IZI
• UDI-Device Identifier: 00884838059054
• UDI-Public: 00884838059054
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: K130842
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• 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 FD20
• Device Catalogue Number: 722012
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/20/2023
• Initial Date FDA Received: 12/29/2023
• Supplement Dates Manufacturer Received: 04/02/2024
• Supplement Dates FDA Received: 04/04/2024
• 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