MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. ALLURA FC; SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED

Model Number ALLURA FC

Device Problem Power Problem (3010)

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

Event Date 04/26/2023

Event Type  malfunction  

Event Description

It has been reported to philips that the internal ups (uninterrupted power supply) is not giving back up.There was no reported patient or user harm.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 system was not in clinical use when the issue occurred.The philips field service engineer (fse) inspected the system onsite and confirmed that the ups was not giving back up.The fse suggested the customer to replace the ups.The customer refused to replace the ups as the system had acquisition pc failure.At the time this complaint was received, philips did not have enough information to exclude that a device malfunction had the potential for death or serious injury on reoccurrence, and as such the complaint was reported.Ups power failures or outages may occur that can cause the allura system to not boot up.Ups failure is considered as a localized power failure that is not caused by the device.Since the malfunction of an external ups power source would not be considered a device malfunction of the allura system, this event would not be reportable.This scenario is not likely to cause or contribute to death or serious injury if it were to reoccur.The codes were updated based on the investigation outcome.

• Brand Name: ALLURA FC
• Type of Device: SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED
• 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: 16903061
• MDR Text Key: 314915492
• Report Number: 3010685285-2023-00002
• Device Sequence Number: 1
• Product Code: JAA
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K022899
• 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 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: 05/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ALLURA FC
• Device Catalogue Number: 723003
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/12/2023
• 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