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

Model Number PRE4001US

Device Problems Suction Problem (2170); Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Date 02/09/2022

Event Type  malfunction  

Event Description

Pt admitted to operating room for colostomy takedown.At eoc, wound vac therapy initiated with prevena and upon placement of teardrop suction device, inadequate suction noted with machine plugged into power source.Large wound vac canister used as replacement.Fda safety report id # (b)(4).

• Brand Name: PREVENA INCISION MANAGEMENT
• Type of Device: NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP
• Manufacturer (Section D): KCI USA, INC.; san antonio TX 78201
• MDR Report Key: 13534712
• MDR Text Key: 285644685
• Report Number: MW5107426
• Device Sequence Number: 1
• Product Code: OMP
• Combination Product (y/n): N
• 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: 02/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PRE4001US
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Sex: Female