Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KINETIC CONCEPTS, INC. ACTIV.A.C.¿ THERAPY SYSTEM; OMP
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

KINETIC CONCEPTS, INC. ACTIV.A.C.¿ THERAPY SYSTEM; OMP Back to Search Results
Model Number WNDACT
Device Problem Collapse (1099)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/23/2021
Event Type  malfunction  
Event Description
On (b)(6) 2021, kci identified the activ.A.C.¿ therapy system had a collapsed power button/switch during the repair process.There is no patient involvement or injury associated with this event.
 
Manufacturer Narrative
Kci found evidence that the device had a collapsed power switch dome.There is no injury associated with this event.Kci is reporting this event found during servicing of the unit as a device malfunction that has the potential to result in injury if the malfunction were to recur.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ACTIV.A.C.¿ THERAPY SYSTEM
Type of Device
OMP
Manufacturer (Section D)
KINETIC CONCEPTS, INC.
san antonio TX 78249
Manufacturer Contact
steven jackson
6203 farinon drive
san antonio, TX 78249
2102556438
MDR Report Key13260270
MDR Text Key289007717
Report Number3009897021-2022-00024
Device Sequence Number1
Product Code OMP
UDI-Device Identifier00878237008188
UDI-Public0100878237008188
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K201571
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Non-Healthcare Professional
Remedial Action Recall
Type of Report Initial
Report Date 01/14/2022
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 Model NumberWNDACT
Device Catalogue Number340020
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/17/2021
Initial Date Manufacturer Received 12/23/2021
Initial Date FDA Received01/14/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/22/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Removal/Correction Number3009897021-5-15-20-001-C
Patient Sequence Number1
-
-