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

Model Number 20421

Device Problems Insufficient Heating (1287); Activation Problem (4042)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/19/2024

Event Type  Injury  

Event 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).

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 Description

No additional information is available.

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
• Type of Device: 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
• MDR Text Key: 336509849
• Report Number: 1216677-2024-00005
• Device Sequence Number: 1
• Product Code: IMD
• UDI-Device Identifier: 00888937025767
• UDI-Public: (01)00888937025767
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K934631
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• 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
• Initial Date Manufacturer Received: 02/02/2024
• Initial Date FDA Received: 02/28/2024
• Supplement Dates Manufacturer Received: 04/05/2024
• Supplement Dates FDA Received: 04/16/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/13/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention