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

Model Number ALLURA XPER FD20

Device Problems Display or Visual Feedback Problem (1184); Radiation Output Failure (4027)

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

Event Date 09/24/2022

Event Type  malfunction  

Event Description

It has been reported to philips that the system was giving an error of image disk full, fluoroscopy not possible.The customer was unable to delete images.There was no reported patient or user harm.A philips field service engineer (fse) inspected the system onsite and confirmed the reported problem.Troubleshooting actions showed a problem with the frontal image disk.The fse recreated the frontal disk and returned the system to use in good working order.Philips has started an investigation of this complaint.A follow up report will be submitted when further information is received.

Manufacturer Narrative

Philips has investigated this complaint.According to the additional information collected, the issue occurred during a planned treatment and the treatment was completed as planned by restarting the system.The philips field service engineer (fse) inspected the system onsite and confirmed the disk image full error and was unable to delete data acquisition of fluoro.Upon troubleshooting, the fse determined the issue with the frontal disk.The fse recreated the frontal disk and the system was returned the system 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 live image 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 image loss issue may resolve, allowing for continuation and completion of the procedure.A loss of live image 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.Philips concludes that this complaint is not reportable.The codes were updated based on the investigation outcome.Device problem code and evaluation method were corrected.

• Brand Name: ALLURA XPER FD
• 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: 16974708
• MDR Text Key: 315785203
• Report Number: 3003768277-2023-02925
• Device Sequence Number: 1
• Product Code: OWB
• UDI-Device Identifier: 00884838059054
• UDI-Public: 00884838059054
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K130638
• 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 FD20
• Device Catalogue Number: 722012
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/24/2022
• Initial Date FDA Received: 05/22/2023
• Supplement Dates Manufacturer Received: 06/22/2023
• Supplement Dates FDA Received: 11/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/22/2012
• 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