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

Device Problems No Audible Alarm (1019); Loss of Power (1475)

Patient Problem Insufficient Information (4580)

Event Date 09/07/2020

Event Type  malfunction  

Event Description

Wound vac was out of power and no alarms went off.

• 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: 10733073
• MDR Text Key: 213004299
• Report Number: 10733073
• 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: 10/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2020
• 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: 10/15/2020
• Event Location: Hospital
• Date Report to Manufacturer: 10/26/2020
• Type of Device Usage: Unknown
• Patient Sequence Number: 1