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	05/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
C-section: incision management system wouldn't shut off once secured to patient.Battery had to be removed in order to get pump to shut off.Foam dressing was secure around entire perimeter - but unable to use on patient due to non-functioning.

• Brand Name: PREVENA PEEL PLACE
• Common Device Name: NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP
• Manufacturer (Section D): KCI USA, INC.; 6203 farinon dr.; san antonio TX 78249
• MDR Report Key: 20236110
• Report Number: 20236110
• Device Sequence Number: 18309593
• Product Code: OMP
• UDI-Device Identifier: 00849554000117
• UDI-Public: (01)00849554000117(17)260930(10)C15091V006
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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): 05/28/2024
• Report Date (Section F): 05/29/2024

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: PRE1001US
• Device Catalogue Number: PRE1001US
• Device Lot Number: C15091V006
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/17/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/17/2024
• 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: 37 YR
• Patient Sex: Female
• Patient Weight: 137 KG
• Date Report Sent to FDA: 05/29/2024