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

Model Number	20421
Medical Device Problem Code	Improper Chemical Reaction (2952)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the transwarmer mattress was activated before putting the baby back in isolette.The isolette was kept warm at 25 degrees celsius in manual mode.Staff reports being unable to obtain temperature.Infant was transported to mri for 3 hours, upon return to nicu, it was noted that the mattress was not warm and the infant had a low body temperature.No patient harm reported.1216677-2024-00063 20421 transwarmer (b)(4).
Additional Manufacturer Narrative
G2: medsun: uf/importer report #: (b)(4).Device location is unknown.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
Updated: b4, d4, g3, g6, h2, h3, h4, h6, h11.Distribution history the complaint product was purchased from pristech products inc on 3/5/24 and sold on between (b)(6) 2024 - (b)(6) 2024.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.Service history record.Service history not applicable for this product.Historical complaint review.A review of the 2-year complaint history showed similar reported complaint conditions.Two confirmed similar complaints were attributed to shipping damage.Product receipt.The complaint product has not been returned to coopersurgical.Visual evaluation.Evaluation of the complaint product could not be completed as the complaint product has not been returned to coopersurgical.If the product should be returned at a later date, it will be evaluated, and any findings will be appended to this investigation.Functional evaluation.Evaluation of the complaint product could not be completed as the complaint product has not been returned to coopersurgical.If the product should be returned at a later date, it will be evaluated, and any findings will be appended to this investigation.Note: device instructions for use (ifu) specify that the infant's core temperature should be taken routinely and regularly.Root cause.Root cause not applicable as the complaint condition was not confirmed.Coopersurgical will continue to monitor this complaint condition for trends.Further corrective action would require the complaint product to be returned to the supplier for evaluation.

• 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: 20694223
• Report Number: 1216677-2024-00063
• Device Sequence Number: 17760084
• Product Code: IMD
• UDI-Device Identifier: 00888937025767
• UDI-Public: (01)00888937025767(10)IL504(17)260828
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: Other,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2025

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 Expiration Date: 08/28/2026
• Device Model Number: 20421
• Device Catalogue Number: 20421
• Device Lot Number: IL504
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/05/2024
• Supplement Date Received by Manufacturer: 01/03/2025
• Initial Report FDA Received Date: 11/15/2024
• Supplement Report FDA Received Date: 01/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/28/2024
• 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
• Patient Age: 1 MO
• Patient Sex: Male