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

Model Number 722011

Device Problems Positioning Failure (1158); Physical Resistance/Sticking (4012)

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

Event Date 02/26/2021

Event Type  malfunction  

Event Description

It has been reported to philips that during an emergency procedure for a patient with an acute infarction, the system stopped working.The patient was moved to another room where the procedure was completed.No harm to the patient has been reported.Philips has started an investigation for this complaint.

Manufacturer Narrative

Philips has investigated this complaint.The analysis of the log file did not show any system malfunction.According to the information collected, the emergency stop button was accidentally pressed when moving the patient onto the table.When the emergency stop button is pressed, all motorized system movements are stopped.After a cold restart the system was back in good working order.

• Brand Name: ALLURA XPER FD
• Type of Device: SYSTEM, X-RAY, ANGIOGRAPHIC
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; veenpluis 4-6; best 5684 PC; NL 5684 PC
• MDR Report Key: 11450777
• MDR Text Key: 239109262
• Report Number: 3003768277-2021-10001
• Device Sequence Number: 1
• Product Code: IZI
• UDI-Device Identifier: 00884838059047
• UDI-Public: 00884838059047
• Combination Product (y/n): N
• PMA/PMN Number: K130842
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• 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?: No
• Device Operator: Health Professional
• Device Model Number: 722011
• Device Catalogue Number: 722011
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 02/26/2021
• Initial Date Manufacturer Received: 02/26/2021
• Initial Date FDA Received: 03/10/2021
• Supplement Dates Manufacturer Received: 02/26/2021
• Supplement Dates FDA Received: 05/12/2021
• Patient Sequence Number: 1