MAUDE Adverse Event Report: SHANGHAI UNITED IMAGING HEALTHCARE CO.,LTD UMI 550; POSITRON EMISSION TOMOGRAPHY AND COMPUTED TOMOGRAPHY SYSTEM

Model Number	UMI 550
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation of the reported event is still ongoing as of the date of this report.A supplemental report will be filed upon completion of the investigation.
Event or Problem Description
07:15 am of j(b)(6)2024, uihs call center received call about pet cooling errors, uihs call center cse worked with site to shut down system to recover the error 2 times with full power off.09:20 am, local cse arrived at the site for dispatch.When cse arrived, he noticed a strong smell of electrical ozone and the system was on.Cse found that kc1 relay cable assy was charred.The halon gas fire suppression was deployed.There is no discoloration and distortion on the cover.There was no one injured due to this failure.Local cse checked system failure parts and replaced with spare parts, and passed quality check on july 3rd,2024.System has been delivered to customer normally.
Additional Manufacturer Narrative
The investigation of the reported event is still ongoing as of the date of this report.A supplemental report will be filed upon completion of the investigation.
Event or Problem Description
At 7:15 am on (b)(6) 2024, a customer service engineer received a call from a customer regarding pet cooling errors.At 09:20 am, the customer service engineer arrived at the site.Upon arrival, he smelled a burnt odor, noticed the scanner was powered on and the halon gas fire suppression system was triggered.The engineer inspected the scanner and found that one end of the pet detector module power cable assembly connected to the relay as well as part of the relay on the side of the pet gantry were charred.There was no discoloration or distortion of the system's side cover near the relay cable assembly.After inspection, the engineer ordered spare parts to replace the damaged power cable assembly and the relay.On (b)(6) 2024, the faulty parts were replaced.The engineer ran the quality check procedures and confirmed the scanner was fully functional.After that, the scanner was turned over to the customer.There was no reported injury during this event.
Additional Manufacturer Narrative
The cse downloaded the logs and sent the damaged relay and power cable assembly back to the service center for inspection.According to the system logs, at 2:43 am, the pet detector lost power, and the pet cooling system compressor fan speed dropped to zero, causing cooling system errors.Expert investigated the damaged relay and power cable assembly.Expert found that the end of the pet detector module power cable assembly connected to the relay terminals, as well as the edge of the relay where the terminals were located, were burned.This indicates that the ignition originated from the connection at the terminals.It was determined that the cause of the fire was a loose connection of the pet detector module power cable assembly to the relay.To further investigate the root cause of the loose cable, both internal factory inspections and field inspections were coordinated.The internal factory inspection was conducted, and there were no loose cables in factory units.For field inspections, we took consideration of the total number of systems on market and acceptance criteria to determine the sample plan for all related devices and cables.We released the field change order (fco) for field inspection and received the required sample quantity.All inspection results were checked, and no loose cables were found.It is statistically concluded that the umi 550, umi 780, and umi vista pet gantry relay cable connections were well connected.The loose cable of this site is a single case, and it is not possible to determine why the cable of this site loosed.The risk assessment was conducted to evaluate the incident's risk and determine if mitigating measures are necessary.The power cables of the pet detector module are connected to the relay for power control.To prevent hazardous situations caused by loose connections, cable aging, or short circuits, which can lead to functional losses, malfunctions, and excessive heat, the risk control required that the covers comply with the ul94 flame retardant standard to reduce the severity of such incidents.It was confirmed that there was no discoloration or distortion on the cover, indicating their effectiveness in preventing potential injury to patients or operators should such a malfunction occur.Regarding the probability, only this case has resulted in a fire in umi 550, umi 780 and umi vista systems, and no injuries were reported.Based on this complaint assessment and the estimated probability of harm occurrence, as well as the severity of harm, the resulting residual risks fall within an acceptable risk area.Therefore, no corrective action is required for the above-listed systems.

• Brand Name: UMI 550
• Common Device Name: POSITRON EMISSION TOMOGRAPHY AND COMPUTED TOMOGRAPHY SYSTEM
• Manufacturer (Section D): SHANGHAI UNITED IMAGING HEALTHCARE CO.,LTD; no.2258 chengbei rd.; jiading district; shanghai, 20180 7; CH 201807
• Manufacturer Contact: shumei wang ; no.2258 chengbei rd. jiading district; shanghai, 20180-7 ; CH 201807
• MDR Report Key: 19999027
• Report Number: 3011015597-2024-00001
• Device Sequence Number: 4362729
• Product Code: KPS
• UDI-Device Identifier: 06971576832057
• UDI-Public: (01)06971576832057(240)88000657
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K193241
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/18/2024

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
• Operator of Device: Health Professional
• Device Model Number: UMI 550
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2024
• Supplement Date Received by Manufacturer: 07/03/2024; 09/23/2024
• Initial Report FDA Received Date: 08/18/2024
• Supplement Report FDA Received Date: 08/21/2024; 10/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/25/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown