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

Device Problems Smoking (1585); Sparking (2595)

Patient Problem Injury (2348)

Event Date 07/12/2019

Event Type  malfunction  

Event Description

The prevena plus 125 wound vac had a low battery and was alarming.The rn was able to locate the electrical cord to plug in the device and located another electrical cord.The power supply (electrical cord) that comes with the device was 5v, 10 w.The power supply that was obtained was 9v.The prevena plus 125 when plugged into the wall gave off a spark and smoked at the connection to the wound vac.The cord was immediately disconnected from the wall and the wound vac was disconnected from the patient.A new setup was obtained and the patient was discharged home that morning.There was injury to the patient.

• Brand Name: PREVENA PLUS
• Type of Device: NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP
• Manufacturer (Section D): KCI USA, INC.; 12930 ih 10 west; san antonio TX 78249
• MDR Report Key: 9278666
• MDR Text Key: 165059673
• Report Number: 9278666
• Device Sequence Number: 1
• Product Code: OMP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/30/2019
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 11/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 11315 DA