MAUDE Adverse Event Report: KCI USA, INC. PREVENA PLUS 25; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP

Model Number 60300EP

Device Problems Failure to Power Up (1476); Charging Problem (2892)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/08/2019

Event Type  Injury  

Event Description

Pt was discharged from hosp with prevena plus dressing.Returned to ed with malfunctioning machine.Machine would not turn on, charging port on the machine did not light up when charger connected.Due to this issue, the pt's therapy was interrupted.Fda safety report id# (b)(4).

• Brand Name: PREVENA PLUS 25
• Type of Device: NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP
• Manufacturer (Section D): KCI USA, INC.
• MDR Report Key: 8535939
• MDR Text Key: 142740662
• Report Number: MW5086024
• 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: Nurse
• Type of Report: Initial
• Report Date: 04/17/2019

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 Operator: Health Professional
• Device Model Number: 60300EP
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/19/2019
• 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 Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Weight: 65