MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. ALLURA XPER FD10; SYSTEM, X-RAY, ANGIOGRAPHIC

Model Number ALLURA XPER FD10

Device Problems Image Display Error/Artifact (1304); Radiation Output Failure (4027)

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

Event Date 03/04/2024

Event Type  malfunction  

Event Description

It was reported to philips that the device's image was failing.The device was in use at the time of reported event.No harm was reported to philips.Philips has started an investigation of this complaint.

Manufacturer Narrative

Philips investigated this complaint.According to the additional information collected, the system was in clinical use when the issue occurred.The procedure was finished as planned.The philips field service engineer (fse) instructed the customer to perform a cold restart of the system.After the customer performed the restart, the artifact issue was solved.The fse analyzed the log file.The customer has a history of climatization problems with their air conditioning, which was the cause of this issue.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.The instructions for use for the allura device recommend using a system restart if there is a system failure.The allura ifu provides instruction on regarding a cold restart (switching the system off and then on again) as well as a ¿fast restart¿ which enables the operator to recover from a system failure faster than switching the system off and on again.If a loss of geometry movement occurs during a procedure, a warm/fast restart or a cold restart may be performed in an attempt to resolve the issue.By using these mitigations provided by the design of the device, the issue may resolve, allowing for continuation and completion of the procedure.A loss of geometry movement that can be resolved by utilizing the design mitigations provided by the device (warm/fast 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 concludes that the complaint is not reportable.The codes were updated based on the investigation outcome.Device problem code was corrected.

• Brand Name: ALLURA XPER FD10
• 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: 18868760
• MDR Text Key: 337292475
• Report Number: 3003768277-2024-01670
• Device Sequence Number: 1
• Product Code: IZI
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K041949
• 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 FD10
• Device Catalogue Number: 722003
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/04/2024
• Initial Date FDA Received: 03/08/2024
• Supplement Dates Manufacturer Received: 03/19/2024
• Supplement Dates FDA Received: 04/05/2024
• 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