MAUDE Adverse Event Report: CORK MEDICAL, LLC NISUS; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP

Model Number	CMPP-100
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
A nisus pump was returned with a complaint alleging that the battery was no longer holding a charge and would not operate from the charger cable as intended.No injuries or harm were reported.Upon inspection, it was discovered that the battery had experienced a short-circuit on the control board, causing thermal damage to the housing interior.No fault was found with the device or its circuitry.The nisus unit functioned as designed, when powered utilizing an external power source.No electrical anomalies or faults can be confirmed associated with the nisus device.Analysis of the event by the supplier of the associated lithium battery confirms the fault was likely the result of a short on the battery control board.This event has been reported to the manufacturer of the associated lithium batteries for further analysis.

• Brand Name: NISUS
• Common Device Name: NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP
• Manufacturer (Section D): CORK MEDICAL, LLC; 8000 castleway drive; indianapolis, in
• MDR Report Key: 10009035
• Report Number: 3010588638-2020-00003
• Device Sequence Number: 14199704
• Product Code: OMP
• UDI-Device Identifier: 00851675007005
• UDI-Public: 00851675007005
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K140022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Inspection,Other
• Type of Report: Initial
• Report Date (Section B): 04/28/2020

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?: No
• Operator of Device: No Information
• Device Expiration Date: 06/25/2024
• Device Model Number: CMPP-100
• Device Catalogue Number: CMPP-100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/10/2020
• Initial Report FDA Received Date: 04/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1