MalfunctionOMP
PREVENA PLUS¿
Received Nov 19, 2025 · Event occurred Sep 22, 2025
Report 23592485 · MDR key 23592485
Device
Generic name
Negative Pressure Wound Therapy Powered Suction Pump
Manufacturer
Kci Usa, Inc.Model number
PRE4010Catalog number
PRE4010
Lot number
C17781V001
Product problems
- Decrease in Pressure
Patient
26 YR · Female
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
AFTER CONNECTING THE PREVENA PLUS THERAPY UNIT TO THE PATIENT'S DRESSING/LINES, DR. [REDACTED] NOTED THAT THE DEVICE WAS NOT PROVIDING THE NEGATIVE PRESSURE THAT THE DEVICE IS SUPPOSED TO. AFTER VARIOUS ATTEMPTS TO ENSURE EVERYTHING WAS CONNECTED PROPERLY AND TURNED ON, DR. [REDACTED] REQUESTED THAT A NEW DEVICE BE OPENED. THE SECOND DEVICE OPENED UP WORKED PROPERLY.