MAUDE Adverse Event Report: COOPERSURGICAL, INC. TRANSWARMER INFANT TRANSPORT MATTRESS; PACK, HOT OR COLD, DISPOSABLE

Model Number	20421
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Portawarmer chemical mattress already activated upon retrieval from supply station.

• Brand Name: TRANSWARMER INFANT TRANSPORT MATTRESS
• Common Device Name: PACK, HOT OR COLD, DISPOSABLE
• Manufacturer (Section D): COOPERSURGICAL, INC.; 95 corporate dr; trumbull CT 06611
• MDR Report Key: 20223607
• Report Number: 20223607
• Device Sequence Number: 17973910
• Product Code: IMD
• UDI-Device Identifier: 00888937025767
• UDI-Public: (01)00888937025767
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 05/20/2024
• Report Date (Section F): 05/20/2024

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: 20421
• Device Catalogue Number: 20421
• Device Lot Number: IL346
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/16/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/16/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 05/20/2024