MAUDE Adverse Event Report: PHILIPS HEALTHCARE ALLURA XPER FD10; SYSTEM, X-RAY, ANGIOGRAPHIC

Model Number 722010

Device Problem Unintended Movement (3026)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

When the investigation has been completed philips will inform the fda.

Event Description

Philips has received through (b)(6) a report submitted ((b)(4)) by a customer.In this report the customer reported: ¿the x-ray tube in room 5 had been repaired, updated during the day of (b)(6) 2018.Was reported ready for use.We re-booted the system at the beginning of the night shift due to that the table was hard to operate (a creaking sound).Hereafter there was an acute patient on the table without x-ray problems.After some hours a new acute patient arrive.Before this patient was brought onto the table we discovered that the table was floating ¿ meaning that it was moving by the leased touch.Therefore it was not possible to complete the kag/pci on this very bad acute patient.Had to move the patient to another room which took approx.10 min.Normally ¿ when treating acute patients ¿ it takes approx.5 min when the patient arrive at the room until the procedure can start¿.Philips has initiated an investigation of this complaint.

Manufacturer Narrative

Philips investigated this complaint.The review of the log files of july 31, 2018 showed that the emergency stop of the system was pressed at 19:03h and was on until the system was shut down at 23.35h on that day.When the emergency stop is activated, the motorized movement is not available and the tabletop is floating.When the procedure with the patient started, the emergency stop was active and therefore the motorized movements were not available and the tabletop was floating.It is unknown why the emergency stop was pressed.The log files showed that two warnings were prompted by the system ¿warning: emergency stop activated; reset to continue¿ (when the emergency stope was pressed) and ¿warning: motorized movement unavailable¿ (when the procedure started).The system was started on the next day and the motorized movement was available.No malfunction of the geometry/table has been identified.No further actions will be taken by philips.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.

• Brand Name: ALLURA XPER FD10
• Type of Device: SYSTEM, X-RAY, ANGIOGRAPHIC
• Manufacturer (Section D): PHILIPS HEALTHCARE; veenpluis 4-6; p.o. box 10.000; best 5680 DA; NL 5680 DA
• MDR Report Key: 8188893
• MDR Text Key: 131484583
• Report Number: 3003768277-2018-00098
• Device Sequence Number: 1
• Product Code: IZI
• Combination Product (y/n): N
• PMA/PMN Number: K041949
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/06/2018

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: 722010
• Device Catalogue Number: 722010
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/06/2018
• Initial Date FDA Received: 12/21/2018
• Supplement Dates Manufacturer Received: 12/06/2018
• Supplement Dates FDA Received: 02/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1