MAUDE Adverse Event Report: CORK MEDICAL NISUS; NEGATIVE PRESSURE WOUND THERAPY PUMP

Model Number	CMPP-100
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event is being reported as a device malfunction that has the potential to result in injury if the malfunction were to recur.The root cause of the malfunction is indeterminate but continues to be investigated by cork medical.The reported malfunction relates to known inherent device risks that are appropriately documented in our risk files.A review of the device history record for this device shows that the device completed all required inspections and testing and was properly functioning at the time of manufacture in april 2024.There is no intervening service history between manufacture and the date of this event.The instructions for use for this device require annual maintenance to be performed by trained cork medical personnel.There is no record of this maintenance being performed.The instructions for use for the device contain many precautions for the use of the device as they relate to risks of fire or thermal damage including not to use the device if exposed to liquids, if dropped or otherwise damaged, and to promptly disconnect the device from the charger when charging is complete.
Event or Problem Description
On august 14, 2025, a cork medical distributor reported a device failure with the description "burned hole in back of device." communication with the distributor confirmed that there were no injuries sustained and no damage to other property.The distributor indicated that the failure was only noticed when the caregiver performed a canister change.At that point, the use of the device was discontinued, and the device was returned to cork medical for evaluation.Cork medical received the device on august 18, 2025.Upon receipt, cork medical engineering staff reviewed the device with quality personnel and observed that the device appeared to have thermal damage to the battery and rear housing.The root cause of the failure could not be determined due to the thermal damage.

• Brand Name: NISUS
• Common Device Name: NEGATIVE PRESSURE WOUND THERAPY PUMP
• Manufacturer (Section D): CORK MEDICAL; 8000 castleway drive; indianapolis IN 46250
• Manufacturer (Section G): CORK MEDICAL; 8000 castleway drive; indianapolis IN 46250
• Manufacturer Contact: david scott ; 8000 castleway drive; indianapolis, IN 46250 ; 8665512580
• MDR Report Key: 23040148
• Report Number: 3010588638-2025-00001
• Device Sequence Number: 9769255
• Product Code: OMP
• UDI-Device Identifier: 00851675007005
• UDI-Public: (01)00851675007005
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K140022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/12/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: CMPP-100
• Device Catalogue Number: CMPP-100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2025
• Initial Report FDA Received Date: 09/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/04/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown