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

Catalog Number ULTDEV01/US

Device Problems Self-Activation or Keying (1557); Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 07/01/2017

Event Type  malfunction  

Event Description

During shift assessment of a patient the wound vacuum control device vacuum pressure setting was checked and noted to be 100 mmhg when it had been set and left previously at 75 mmhg.The patient's mother indicated that she observed that "the device keeps changing screens and looks like something is hitting the buttons".The nurse then corrected the setting and locked the controls.The nurse then observed that the display was indicating that the 1 and 2 keys were being selected although no one was touching the device.The device was swapped with a second wound vacuum control device with no further problems noted.Manufacturer response for wound vacuum control device, (brand not provided) (per site reporter).The manufacturer hasn't yet had an opportunity to evaluate the device involved.

• Brand Name: V.A.C.ULTA
• Type of Device: NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP
• Manufacturer (Section D): KCI USA, INC.; 4958 stout dr.; san antonio TX 78219
• MDR Report Key: 6767403
• MDR Text Key: 81832649
• Report Number: 6767403
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2017
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: ULTDEV01/US
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/03/2017
• Device Age: 6 YR
• Event Location: Hospital
• Date Report to Manufacturer: 07/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NOT APPLICABLE.