MAUDE Adverse Event Report: KCI USA, INC. PREVENA PLUS INCISION MANGEMENT SYSTEM; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP

Model Number PRE4001US

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Date 09/15/2020

Event Type  malfunction  

Event Description

Dressing applied to patient; machine would not decompress.Fda safety report id # (b)(4).

• Brand Name: PREVENA PLUS INCISION MANGEMENT SYSTEM
• Type of Device: NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP
• Manufacturer (Section D): KCI USA, INC. ; san antonio TX 78249
• MDR Report Key: 10592692
• MDR Text Key: 209020970
• Report Number: MW5096894
• Device Sequence Number: 1
• Product Code: OMP
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2022
• Device Model Number: PRE4001US
• Device Lot Number: 7607935V006
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 26 YR