MAUDE Adverse Event Report: C2DX, INC T PUMP; MUL T BLANKET; MUL T PAD; T PUMP; T-PUMP; TEMP PUMP PRO

Model Number TP700

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

Patient Problem Burn(s) (1757)

Event Date 05/01/2023

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.

Event Description

Cusomter reported second-degree patient burn with use of tpump system.

• Brand Name: T PUMP
• Type of Device: MUL T BLANKET; MUL T PAD; T PUMP; T-PUMP; TEMP PUMP PRO
• Manufacturer (Section D): C2DX, INC; 555 e eliza st suite a; schoolcraft MI 49087
• MDR Report Key: 16941215
• MDR Text Key: 315323454
• Report Number: 3015489752-2023-00002
• 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: Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 05/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2023
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Prefer Not To Disclose