MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. ALLURA XPER FD10/10; SYSTEM, X-RAY, ANGIOGRAPHIC

Model Number ALLURA XPER FD10/10

Device Problem Difficult or Delayed Activation (2577)

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

Event Date 01/26/2023

Event Type  malfunction  

Event Description

It has been reported to philips that,system had a delay in boot up.System was not in clinical use.No harm has been reported to philips.

Manufacturer Narrative

Philips has investigated this complaint.The philips field service engineer (fse) inspected the system onsite and confirmed that there was nothing wrong with the philips system.Upon functional testing, it was found that this was more of a user complaint than an error with the system.The user doesn¿t want the system turned off.Philips system was working as per intended use, system handed over in working order.Based on service history review, the issue did not reoccur.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.Based on the new information, this complaint is evaluated as not reportable.The codes were updated based on the investigation outcome.

• Brand Name: ALLURA XPER FD10/10
• 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: 16429840
• MDR Text Key: 310093156
• Report Number: 3003768277-2023-00996
• 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 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 FD10/10
• Device Catalogue Number: 722005
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/26/2023
• Initial Date FDA Received: 02/23/2023
• Supplement Dates Manufacturer Received: 12/11/2023
• Supplement Dates FDA Received: 12/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/03/2020
• 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