MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY PATIENT WARMING SYSTEM PACK

Medical Device Problem Code	Sparking (2595)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/15/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported the power supply to their patient warming system pack sparked.No report of injury.
Additional Manufacturer Narrative
Investigation of this event is currently in process.A follow-up report will be submitted when additional information becomes available.
Additional Manufacturer Narrative
Following the reported event, the user facility received a replacement power supply for their patient warming system pack.A steris service technician inspected the power supply subject of the reported event and stated that the direct current (dc) output connector on the patient warming system pack was physically damaged.When the inner conductor contacted the outer conductor, sparks may have been created from electricity arcing.The patient warming system pack was returned to service and no additional issues have been reported.

• Brand Name: PATIENT WARMING SYSTEM PACK
• Common Device Name: PATIENT WARMING SYSTEM PACK
• Manufacturer (Section D): STERIS CORPORATION - MONTGOMERY; 2720 gunter park drive east; montgomery AL 36109
• Manufacturer (Section G): STERIS CORPORATION - MONTGOMERY; 2720 gunter park drive east; montgomery AL 36109
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060 ; 4403927453
• MDR Report Key: 15627748
• Report Number: 1043572-2022-00065
• Device Sequence Number: 6184288
• Product Code: DWJ
• UDI-Device Identifier: 00724995195250
• UDI-Public: 00724995195250
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2022

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2022
• Supplement Date Received by Manufacturer: 08/15/2022
• Initial Report FDA Received Date: 10/18/2022
• Supplement Report FDA Received Date: 11/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/07/2021
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown