MAUDE Adverse Event Report: OWENS & MINOR DISTRIBUTION, INC. MEDICHOICE; PACK, HOT OR COLD, WATER CIRCULATING

Model Number	HTB060
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Patient with septic fever, cooling blanket ordered.When attaching the cooling blanket to the air tubing, the blanket would not hold air.Troubleshooting did not change outcome.A new warming blanket was obtained and functioned without issue.

• Brand Name: MEDICHOICE
• Common Device Name: PACK, HOT OR COLD, WATER CIRCULATING
• Manufacturer (Section D): OWENS & MINOR DISTRIBUTION, INC.; 9120 lockwood blvd.; mechanicsville VA 23116
• MDR Report Key: 20662034
• Report Number: 20662034
• Device Sequence Number: 20659186
• Product Code: ILO
• UDI-Device Identifier: 10885632112621
• UDI-Public: (01)10885632112621
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 10/03/2024
• Report Date (Section F): 10/03/2024

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
• Device Model Number: HTB060
• Device Catalogue Number: HTB060
• Device Lot Number: D1300424
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 11/12/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/12/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 45 YR
• Patient Sex: Unknown
• Date Report Sent to FDA: 10/03/2024