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 11/10/2023

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 tracy at memorial hermann-woodlands indicated that the patient laid on the tpad for 24 hours with minimal breaks to get up and walk around.The site was checked by a nurse every 12 hours on shift-change.Tracy did not know the settings that were used, but assumed the pump was in continuous mode and knew the t/pump was not set to the hottest temperature setting.The pad did not feel hot to the touch.The patient was not in pain from the burn on her back.She realized she had a burn when she scratched her back and felt a blister.The patient was not experiencing any neuropathy.

Event Description

Customer reported patient was laying on heating pad almost 24 hours when rn was notified burns and blisters were on patient's back while using tpump system.

• Brand Name: T PUMP
• Type of Device: Pack, hot or cold, water circulating
• Manufacturer (Section D): C2DX, INC.; 555 e elizaz st suite a; schoolcraft MI 49087
• MDR Report Key: 18184712
• MDR Text Key: 328737072
• Report Number: 3015489752-2023-00005
• 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: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 11/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2023
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2023
• Date Manufacturer Received: 11/20/2023
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female