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

Model Number ALLURA XPER FD10

Device Problems Emergency Power Failure (1205); Activation Failure (3270)

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

Event Date 12/07/2022

Event Type  malfunction  

Event Description

It has been reported that the system could not start due to defective ups.No harm to the patient has been reported to philips.The available information does not indicate if the system was in clinical use or not when the issue took place.We are conservatively reporting this event at this point of time.A follow up report will sent if any further information is available.

Manufacturer Narrative

Philips has investigated this complaint.The customer reported issue was system does not start with defective ups and related to a product of 3rd party.Hence, it is recommended forwarding this issue directly to the supplier or manufacturer of the toshiba uninterruptible power supply (ups).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 recurrence, 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 recur.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: dusty leppert ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 16008104
• MDR Text Key: 305846958
• Report Number: 3003768277-2022-01654
• Device Sequence Number: 1
• Product Code: IZI
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K130842
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• 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 FD10
• Device Catalogue Number: 722010
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/07/2022
• Initial Date FDA Received: 12/19/2022
• Supplement Dates Manufacturer Received: 11/13/2023
• Supplement Dates FDA Received: 11/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/20/2012
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1