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 Problems No Device Output (1435); Radiation Output Failure (4027)

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

Event Date 09/21/2022

Event Type  malfunction  

Event Description

It has been reported to philips that on (b)(6) 2022 the system failed.There was a patient with a heart attack on the table.The patient had to be moved to another room.No harm has been reported to philips.To date, no further information was received.Philips has started an investigation and a follow up report will be submitted when further information is received.

Manufacturer Narrative

Philips has investigated this complaint.There was no additional information regarding if the patient's condition (mi)worsened during the transfer/delay and if the patient required any additional treatment during the transfer.The philips remote service engineer (rse) analyzed the system remotely and confirmed the reported issue.Upon troubleshooting, the rse determined further grid switch errors and tube errors reported in the logging.The customer had been quoted for a new tube.However the service quote provided by philips was not accepted by the customer, therefore no further action could be performed by philips.The codes were updated based on the investigation outcome.Device problem code was corrected.

• Brand Name: ALLURA XPER FD10/10
• 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
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; veenpluis 4-6; best 5684 PC; NL 5684 PC
• Manufacturer Contact: dusty leppert ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 15715932
• MDR Text Key: 304886015
• Report Number: 3003768277-2022-00731
• 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?: 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?: No
• Initial Date Manufacturer Received: 09/21/2022
• Initial Date FDA Received: 11/02/2022
• Supplement Dates Manufacturer Received: 10/03/2023
• Supplement Dates FDA Received: 10/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/08/2007
• 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