MAUDE Adverse Event Report: KCI USA, INC. KCI 3M WOUND VAC ULTA NWPT; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP

Device Problems Device Alarm System (1012); Mechanical Problem (1384); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Date 02/12/2021

Event Type  malfunction  

Event Description

Hospital wound vac ulta pump not functioning at time of assessment.Wound vac machine indicated "functioning at 125 mmhg", no alarms.With removal of kerlix dressing to foot, black foam dressing not compressed.With separation of tubing from pt and wound vac machine and then removal of canister from machine, there continued to be no alarm and machine indicated "functioning at 125 mmhg.Cs contacted for new vac ulta machine, connected new machine to pt.(b)(6), kci wound vac representative was on the unit to check in with this rn once advised by cs that machine had malfunctioned.All details of found malfunctioning machine discussed with kci rep.Unclear how long machine not functioning, wound did look improved from (b)(6) 2021 assessment, no concern for deteriorating wound due to machine malfunction.Fda safety report id# (b)(4).

• Brand Name: KCI 3M WOUND VAC ULTA NWPT
• Type of Device: NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP
• Manufacturer (Section D): KCI USA, INC. ; san antonio TX 78249 2248
• MDR Report Key: 12016607
• MDR Text Key: 257423235
• Report Number: MW5101943
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 06/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 64 YR