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

Model Number ALLURA XPER FD10

Device Problems Activation Failure (3270); Unexpected Shutdown (4019)

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

Event Date 03/29/2023

Event Type  malfunction  

Event Description

It has been reported to philips that the system shut down during a case and would not power back on.The system was in clinical use.There was no reported patient or user harm.

Manufacturer Narrative

Philips has investigated this complaint.Customer reported that the system shut down during a case and not able to be powered back on.When service engineer contacted customer for onsite service, customer confirmed that they have gotten the system back up and running it was due to power outage.The philips engineer suggested onsite service, since the customer resolved the issue, the service has been cancelled and no service has been provided from the philips.At the time this complaint was received, philips did not have enough information to exclude a potential for serious injury 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.Based on the investigation results, this scenario includes situation in which the main hospital power supply is not functioning or there is localized power failure that is not caused by the allura device.Since the malfunction of an external power source would not be considered a device malfunction of the allura system, this event would not be reportable.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: 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: 16713037
• MDR Text Key: 313029192
• Report Number: 3003768277-2023-02209
• Device Sequence Number: 1
• Product Code: IZI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K041949
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: 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: 03/29/2023
• Initial Date FDA Received: 04/11/2023
• Supplement Dates Manufacturer Received: 05/16/2023
• Supplement Dates FDA Received: 11/07/2023
• 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