MAUDE Adverse Event Report: KCI ACTIVAC; WOUND VAC

Model Number VCQK14253

Device Problems Partial Blockage (1065); Device Displays Incorrect Message (2591)

Patient Problem No Information (3190)

Event Date 08/07/2014

Event Type  Injury  

Event Description

Wound vac with message of blockage- wound vac non functioning.Rn notified kci representative.He had rn perform several tests and determined vac was not working.Wound vac was replaced.

• Brand Name: ACTIVAC
• Type of Device: WOUND VAC
• Manufacturer (Section D): KCI; 370 greenbriar dr. suite a1; charlottsville VA 22901
• MDR Report Key: 4024379
• MDR Text Key: 19797503
• Report Number: MW5037738
• 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: Nurse
• Type of Report: Initial
• Report Date: 08/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: VCQK14253
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR
• Patient Weight: 64