MAUDE Adverse Event Report: KCI USA, INC. V.A.C. ULTA THERAPY SYSTEM; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP

Device Problems No Display/Image (1183); Failure to Power Up (1476); Battery Problem (2885)

Patient Problem Insufficient Information (4580)

Event Date 02/16/2021

Event Type  malfunction  

Event Description

Writer called in to room by patient asking about her wound vacuum not being lit up.Upon entering room, the wound vacuum screen black.The connections were checked and outlets were changed.The wound vacuum screen was showing a flashing battery screen.The wound vacuum was tried in several more outlets and would no longer turn on.

• Brand Name: V.A.C. ULTA THERAPY SYSTEM
• 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: 11473069
• MDR Text Key: 239484281
• Report Number: 11473069
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 02/16/2021

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: No Information
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/16/2021
• Event Location: Hospital
• Date Report to Manufacturer: 03/12/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/12/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 9125 DA