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

Model Number ALLURA XPER FD20 OR TABLE

Device Problems Computer Software Problem (1112); Activation Failure (3270)

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

Event Date 12/01/2022

Event Type  malfunction  

Event Description

It has been reported to philips that the system software crashed.The system was in clinical use.No harm has been reported to philips.A philips service engineer inspected the system on site.It was identified that ippc memory was not recognized.The memory was removed, physically cleaned and re-installed.The system was returned to use in good working order.

Manufacturer Narrative

Philips has investigated this complaint.According to the additional information collected, the system was in clinical use when issue was occurred, and the patient was moved to another operating room to complete the procedure.The philips field service engineer (fse) inspected the system onsite and confirmed that the system software had crashed.Review of the system log file showed a problem with ippc.Upon functional testing fse found that the memory was not recognize and ippc host cannot run properly due to the high temperature in equipment room.Fse turned on the air conditioner and re-inserted the memory module of the ippc host.After reinserted the memory module of the ippc host, the system was returned to use in good working order.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.The air conditioner in the machine room is off for unknown reasons.The temperature in the equipment room is too high.As a result, the ippc host cannot run properly.Based on the new information, this complaint is evaluated as not reportable.The codes were updated based on the investigation outcome.Device problem code and evaluation method code was corrected.

• Brand Name: ALLURA XPER FD
• 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: 15973446
• MDR Text Key: 305637551
• Report Number: 3003768277-2022-01514
• Device Sequence Number: 1
• Product Code: IZI
• UDI-Device Identifier: 00884838059085
• UDI-Public: 00884838059085
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K130842
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• 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 FD20 OR TABLE
• Device Catalogue Number: 722023
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/01/2022
• Initial Date FDA Received: 12/13/2022
• Supplement Dates Manufacturer Received: 02/09/2023
• Supplement Dates FDA Received: 11/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/07/2013
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1