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

Model Number 20421

Device Problem Use of Device Problem (1670)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/06/2023

Event Type  malfunction  

Manufacturer Narrative

Customer has indicated that the product was discarded and can not be returned to cooper surgical for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that while using the device, the patient suffered a burn of unknown degree.The patient condition is unknown as they were transferred to another facility.The customer stated that the device was used in conjunction with an additional heat source.Device was discarded by customer.No additional information is available.1216677-2023-00142 20421 transwarmer 2023-10-0000176.

Event Description

No additional information is available.

Manufacturer Narrative

Distribution history the complaint product was purchased from pristech products inc.By csi.Manufacturing record review manufacturing record review not applicable to this product.Incoming inspection review a review of the incoming inspection record could not be performed because the complaint product lot/serial number was not provided.Should the complaint product lot/serial 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.1 complaint reported a burn to an infant, however, the complaint could not be confirmed.Product receipt the complaint product has not been returned to cooper surgical.Visual evaluation of the complaint product could not be completed as the complaint product has not been returned to cooper surgical.Functional evaluation of the complaint product could not be completed as the complaint product has not been returned to cooper surgical.Note: verified with the customer per correspondence that this device was used with an additional heat source, the omni giraffe bed despite the warning indicated on the device and ifu: do not apply an additional heat source to the infant when using this product.Verified both the product and the ifu state: do not leave on skin longer than 10 minutes.Root cause root cause not applicable as the complaint condition was not confirmed.Cooper surgical will continue to monitor this complaint condition for trends.No further corrective action is necessary, as the complaint condition was not confirmed.

• Brand Name: TRANSWARMER 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: 18012821
• MDR Text Key: 326629442
• Report Number: 1216677-2023-00142
• Device Sequence Number: 1
• Product Code: IMD
• UDI-Device Identifier: 00888937025767
• UDI-Public: (01)00888937025767
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K934631
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 12/19/2023

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: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/06/2023
• Initial Date FDA Received: 10/26/2023
• Supplement Dates Manufacturer Received: 12/08/2023
• Supplement Dates FDA Received: 12/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other