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

Model Number	20421
Medical Device Problem Codes	Insufficient Heating (1287); Activation Problem (4042)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/19/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an infant was admitted to the stabilization room on transwarmer, in incubator on (b)(6), 2024.Baby had a low admission temperature.Upon checking the transwarmer it was cold, contributing the low admission temperature.A second transwarmer from the same lot was opened and found to also not activate.Device instructions for use (ifu) specify that the infant's core temperature should be taken routinely and regularly.Attempts for further details were made, but no additional information was provided.1216677-2024-00005 20421 transwarmer (b)(4).
Additional Manufacturer Narrative
G2: foreign: united kingdom.Other: medicines and healthcare products regulatory agency (mhra) 2024/001/031/501/007 device location is unknown.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
No additional information is available.
Additional Manufacturer Narrative
Distribution history the complaint product was purchased from pristech products inc.On 4/14/23 and sold between 4/25/23 - 8/7/23.Manufacturing record review dhr in iqc record-(b)(4) was reviewed and no non-conformities, related to the complaint condition, were noted.Incoming inspection review iqc record-(b)(4) attached 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.There were several complaints that could not be confirmed, along with 2 complaint that were sent to the supplier for evaluation and found to have tears in the mattresses which caused them to activate and therefore, confirming the complaints.In those complaints, the damage to the product was 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.Attempts for further details were made, but no additional information was provided.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
• Manufacturer (Section G): COOPERSURGICAL, INC.; 75 corporate drive; trumbull; CT 06611
• Manufacturer Contact: michael marone ; 50 corporate drive; trumbull, CT 06611 ; 4752651582
• MDR Report Key: 18802036
• Report Number: 1216677-2024-00005
• Device Sequence Number: 7143815
• Product Code: IMD
• UDI-Device Identifier: 00888937025767
• UDI-Public: (01)00888937025767
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2024

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 Expiration Date: 10/12/2025
• Device Model Number: 20421
• Device Catalogue Number: 20421
• Device Lot Number: IL324
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/02/2024
• Supplement Date Received by Manufacturer: 04/05/2024
• Initial Report FDA Received Date: 02/28/2024
• Supplement Report FDA Received Date: 04/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/13/2023
• 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: Required Intervention
• Patient Sex: Unknown