MAUDE Adverse Event Report: KCI USA, INC. PREVENA¿ PEEL PLACE¿; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP

Model Number	PRE1001US
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During a coronary artery bypass graft (on pump), the prevena sponge was placed on the patient, and the device failed to maintain suction.A switch was made to another large wound vac machine and sponge suction became steady.No harm to patient, prevena device was given to coordinator after the case to work with vendor regarding suction concern.

• Brand Name: PREVENA¿ PEEL PLACE¿
• Common Device Name: NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP
• Manufacturer (Section D): KCI USA, INC.; 12930 ih 10 west; san antonio TX 78249
• MDR Report Key: 24214611
• Report Number: 24214611
• Device Sequence Number: 15776328
• Product Code: OMP
• UDI-Device Identifier: 00849554000117
• UDI-Public: (01)00849554000117(17)280331
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 01/20/2026
• Report Date (Section F): 01/20/2026

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
• Device Model Number: PRE1001US
• Device Catalogue Number: PRE1001US
• Device Lot Number: C21716V005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/29/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/29/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 81 YR
• Patient Sex: Unknown
• Date Report Sent to FDA: 01/20/2026