MAUDE Adverse Event Report: COOPERSURGICAL, INC. TRANSWARMER INFANT TRANSPORT MATTRESS; REACTIVE-GEL HEATING PAD

Model Number	20421
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	Hypothermia (1915)
Date of Event	10/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the activation plate was activated, but the mattress did not get warm.The warming mat was used in the initial care of premature babies, but it did not warm up during initial care.As a result, the patient suffered hypothermia, with a body temperature of 34.2 degrees celsius.Attempts have been conducted, but no additional information has been provided.1216677-2025-00043 20421 transwarmer (b)(4).
Additional Manufacturer Narrative
G2: foreign: switzerland.Device is to be returned by the distributor.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
Updated: b4, d9, g3, g6, h2, h3, h4, h6, h11.Distribution history: the complaint product was purchased from pristech products inc.On 1/13/25 and sold between 1/17/25-8/29/25.Manufacturing record review: dhr was reviewed and no non-conformities, related to the complaint condition, were noted.Incoming inspection review: iqc record was reviewed and no non-conformities, related to the complaint condition, were noted.Historical complaint review: a review of the 2-year complaint history showed 2 complaints with similar reported complaint conditions; however, they could not be confirmed.Product receipt: the complaint product 20421 lot il650 qty.1 was returned on 11/11/25.The lot number of the returned product matched the lot number reported.Visual evaluation: visual examination of the complaint product revealed physical damage.A rip at the seam of the mattress was found.The content of the mattress was opaque and firm due to the opening.Photos submitted by the customer also show a portion of the mattress to be opaque, white and crystalline which is consistent with the returned product evaluation and indicates that the damage occurred prior to return shipping back to coopersurgical for evaluation.Functional evaluation: complaint product was evaluated by the supplier.It was found to be damaged, most likely, by the case being dropped during transit.This caused the seam to split, activating the solution.Note: the mattress was damaged and activated, it would not function properly when the customer attempted to use it, which confirms the complaint.Any relevent customer or clinical information: there was no relevant customer or clinical information provided.Root cause: while no definitive root cause could be reliably determined, the cause may be attributed to damage incurred in transit.Coopersurgical will continue to monitor this complaint condition for trends.No further corrective action is necessary.
Event or Problem Description
No additional information.

• Brand Name: TRANSWARMER INFANT TRANSPORT MATTRESS
• Common Device Name: REACTIVE-GEL HEATING PAD
• Manufacturer (Section D): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611 1350
• Manufacturer (Section G): COOPERSURGICAL, INC.; 75 corporate drive; trumbull CT 06611 1350
• Manufacturer Contact: michael marone ; 50 corporate drive; trumbull, CT 06611-1350 ; 4752651582
• MDR Report Key: 23312357
• Report Number: 1216677-2025-00043
• Device Sequence Number: 14699699
• Product Code: IMD
• UDI-Device Identifier: 00888937025767
• UDI-Public: (01)00888937025767(10)IL650
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K934631
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Distributor
• Initial Reporter Occupation: 505
• Type of Report: Initial,Followup
• Report Date (Section B): 12/24/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 20421
• Device Catalogue Number: 20421
• Device Lot Number: IL650
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/01/2025
• Supplement Date Received by Manufacturer: 12/05/2025
• Initial Report FDA Received Date: 10/16/2025
• Supplement Report FDA Received Date: 12/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/13/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown