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 Positioning Failure (1158)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/28/2023

Event Type  Injury  

Event Description

It has been reported to philips that the table locked during a procedure.A system reboot was performed without resolve.The event occurred mid-examination and patient already had a sheath in that couldn¿t be removed.The patient was moved to another room to complete the procedure.It was reported that there was patient harm.We are conservatively reporting this event as a serious injury as the extent of the harm is unknown.A follow up report will be submitted when further information is received.A philips field service engineer (fse) inspected the system onsite and identified that the table was heavily contaminated with consumables debris and caps.The fse removed all of the discarded debris that had entered the table, refitted all of the covers, calibrated the table and returned the system to use in good working order.

Manufacturer Narrative

Philips has investigated this complaint.According to the additional information received, the device was in diagnosis procedure when the issue occurred, and the procedure got completed by moving the patient to other lab when available and this issue was occurring intermittently.The philips field service engineer (fse) inspected the system onsite and confirmed that the table movements were not possible.Upon functional testing the fse found that the fault was traced to table base connection board (ttcb) in base of ad7 table.To resolve the reported issue the fse stripped down table and cleaned heavily contaminated area, removed all discarded caps/consumables that had entered table, carried out all table potentiometer calibrations and table adjustments and re-installed all the covers back to its original position, which was temporarily resolved the issue.The same issue reoccurred after 5 days, to resolve the reported issue the fse replaced the tbcb.After which, the system was returned to use in good working order.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: 17257513
• MDR Text Key: 318465488
• Report Number: 3003768277-2023-03925
• Device Sequence Number: 1
• Product Code: IZI
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K041949
• 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
• 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?: Yes
• 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?: No
• Initial Date Manufacturer Received: 06/28/2023
• Initial Date FDA Received: 07/05/2023
• Supplement Dates Manufacturer Received: 09/29/2023
• Supplement Dates FDA Received: 10/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/08/2008
• 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
• Patient Outcome(s): Other