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

Model Number	20421
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Skin Disorders (4543)
Date of Event	11/22/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device location is unknown.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that a 22-week infant was experiencing skin breakdowns after using the transwarmer mattress.From the reports of the nurses present, there was one blanket placed between the baby and the mattress at the time of delivery.The infant was having umbilical lines placed so the infant remained on the mattress for much longer than the recommended 10-minute guideline in order to keep him warm.After line placement, it was found that the infant was cold, so the team left the baby on the mattress but replaced the blanket with a fleece liner.No additional information is available.20421 transwarmer 2024-11-0000467.
Additional Manufacturer Narrative
Updated: b4, g3, g6, h2, h3, h6, h11.Correction: a2.Distribution history: the complaint product was purchased from pristech products inc.Manufacturing record review: a review of the device history record could not be performed because the lot number was not provided.Should the complaint product lot/serial number be provided going forward, the device history record will be reviewed, and this complaint amended accordingly.Incoming inspection review: a review of the incoming inspection record could not be performed because the complaint product lot number was not provided.Should the complaint product lot number be provided going forward, the incoming inspection report will be reviewed, and this complaint amended accordingly.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, however both complaints could not be confirmed.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.Any relevent customer or clinical information: the customer advised the infant was on the mattress longer than the 10-minutes recommended in the ifu and regular skin/temperature checks were most likely not performed per the instructions found on the ifu.Root cause: root cause not applicable as the complaint condition was not confirmed.Coopersurgical will continue to monitor this complaint condition for trends.No further corrective action is necessary, as the complaint condition was not confirmed.Requested further information from the customer to support this investigation.
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: 20918299
• Report Number: 1216677-2024-00067
• Device Sequence Number: 8320162
• Product Code: IMD
• UDI-Device Identifier: 00888937025767
• UDI-Public: (01)00888937025767
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2025

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: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/22/2024
• Supplement Date Received by Manufacturer: 01/24/2025
• Initial Report FDA Received Date: 12/12/2024
• Supplement Report FDA Received Date: 01/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sex: Male