MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. BRILLIANCE; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Model Number BRILLIANCE 64 UPGRADES

Device Problem Crack (1135)

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

Event Date 08/20/2021

Event Type  malfunction  

Manufacturer Narrative

We have not completed our investigation of this event.We will file a follow-up emdr at the completion of the investigation.Internal cross reference: complaint (b)(4).

Event Description

The issue reported was that during a planned maintenance (pm) visit it was discovered that one of the welds on the heat exchanger had a crack in the seam.Based on the information available at this time, this event has been determined to be reportable.

Manufacturer Narrative

The issue reported was that during a planned maintenance (pm) visit, it was discovered that one of the welds on the heat exchanger had a crack in the seam.A philips field service engineer (fse) confirmed the heat exchanger was not loose in anyway.The system was not in clinical use when this occurred.The fse replaced the cooling unit at the site and returned the system to the customer for clinical use.The faulty heat exchanger was returned for investigation.The analysis from the faulty heat exchanger concluded: the cracked weld seam is one of 12 (6 on each side) weld seams, the design is symmetric.The welds connect the heat exchanger to the gantry mounting plate (bracket).The mounting plate is mounted with 4 screw connections on each side to the ct gantry when the cooling unit is installed.The crack found was located at the inlet side of the heat exchanger.A mechanical stability simulation was done and the result was that even with 4 broken welds the safety factor was still sufficient.Conclusion: there is not a hazard situation of detached component (tube heat exchanger) expelled for this case.An analysis was also performed by the supplier which concluded the following: the most plausible root cause is temperature cycling fatigue damage related to the manufacturing date of cooling unit of more than 10 years old (whilst the lifetime is 10 years).The probable cause was temperature cycling fatigue damage on cooling units on average more than 10 years old.Therefore, based on the investigation performed, this event is considered a non-reportable event.The system did not cause or contribute to a death or serious injury, or serious deterioration and would not cause a death or serious injury, or serious deterioration if this event were to recur.Internal cross reference: complaint pr# (b)(4).

• Brand Name: BRILLIANCE
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• 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: beth johnson ; 100 park avenue, suite 300; orange village, OH 44122
• MDR Report Key: 12418847
• MDR Text Key: 273782557
• Report Number: 3015777306-2021-10010
• Device Sequence Number: 1
• Product Code: JAK
• UDI-Device Identifier: 00884838083325
• UDI-Public: 00884838083325
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K033326
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• 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 Model Number: BRILLIANCE 64 UPGRADES
• Device Catalogue Number: 728231
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 08/20/2021
• Initial Date Manufacturer Received: 08/20/2021
• Initial Date FDA Received: 09/02/2021
• Supplement Dates Manufacturer Received: 08/20/2021
• Supplement Dates FDA Received: 12/10/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1