MAUDE Adverse Event Report: C2DX INC. T PUMP; Pack, hot or cold, water circulating

Model Number TP700

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Burn(s) (1757)

Event Date 02/21/2024

Event Type  Injury  

Manufacturer Narrative

Per the device ifu: rechecking the patient's skin condition: recheck the entire area of the patient's skin condition that is in contact with the pad at least every 30 minutes.Note any change in the skin integrity that relates to: excessive moisture - dry the skin surface by wiping away the moisture.Color of the epidermis skin texture - patient's skin condition is acceptable to continue therapy evaluation report is attached.

Event Description

Customer reported that the tpad was under the patient, and was turned on early in the evening, turned off for an amount of time, and when the went to turn the t/pump back on, they noticed the burn and imprint of the pad on the patient's skin.The biomed is under the impression that the t/pump was on high temperature and is assuming that it was on continuous mode, as that is the default mode.

• Brand Name: T PUMP
• Type of Device: Pack, hot or cold, water circulating
• Manufacturer (Section D): C2DX INC.; 555 e eliza st suite a; schoolcraft MI 49087
• MDR Report Key: 18867229
• MDR Text Key: 337234508
• Report Number: 3015489752-2024-00001
• Device Sequence Number: 1
• Product Code: ILO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K073675
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Biomedical Engineer
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 03/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TP700
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/04/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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