BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    ACTIV.A.C. THERAPY SYSTEM

    MDR report key: 10141390 · Received June 10, 2020

    Report

    Report Number
    3009897021-2020-00231
    Event Type
    Malfunction
    Date Received
    June 10, 2020
    Date of Event
    February 20, 2020
    Report Date
    September 29, 2020
    Manufacturer
    KINETIC CONCEPTS, INC.
    Product Code
    OMP
    UDI-DI
    00849554001848
    PMA / PMN Number
    K201571
    Removal / Correction Number
    3009897021-5-15-20-001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    MDR-3009897021-2020-00231 SUBMITTED ON 10-JUN-2020 NOTED THAT IT WAS A SUMMARY REPORT FOR 1 EVENT FOUND IN REPAIR AND MULTIPLE SECTIONS WERE INADVERTENTLY LEFT BLANK. CORRECTION THIS REPORT IS FOR ONE EVENT ASSOCIATED WITH SERIAL NUMBER (B)(6) INFORMATION IN B5 AND H10 HAVE BEEN UPDATED TO REFLECT SUCH AND BLANK SECTIONS WERE COMPLETED. SECTION B3 DATE OF EVENT NOTED (B)(6) 2020 CORRECTION SECTION B3 DATE OF EVENTL (B)(6) 2020 SECTION D1 BRAND NAME NOTED ACTIV.A.C.¿ ION PROGRESS¿ REMOTE THERAPY MONITORING SYSTEM CORRECTION D4 BRAND NAME: ACTIV.A.C.¿ THERAPY SYSTEM SECTION D4 MODEL # NOTED WNDARM CORRECTION D4MODEL #: WNDACT G1 CONTACT OFFICE EMAIL NOTED (B)(6) CORRECTION G1 CONTACT OFFICE EMAIL: (B)(6) SECTION G5 PMA/510(K) NOTED K063692 CORRECTION SECTION G4 PMA/510(K) K201571. SECTION G7 TYPE OF REPORT WAS BLANK CORRECTION SECTION G7 TYPE OF REPORT 30-DAY. BASED ON THE CORRECTIONS; KCI'S ASSESSMENT REMAINS THE SAME. DURING THE REPAIR PROCESS, KCI FOUND EVIDENCE THAT THE DEVICE HAD A COLLAPSED POWER SWITCH DOME. THE POWER SWITCH WAS REPLACED. THERE IS NO PATIENT INVOLVEMENT AND THERE IS NO INJURY REPORTED TO KCI 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. DISCLAIMER: THIS INFORMATION IS SUBMITTED PURSUANT TO 21 CFR 803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT A KINETIC CONCEPTS, INC. PRODUCT MALFUNCTIONED, IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.

    Description of Event or Problem · 0

    KCI IDENTIFIED THE ACTIV.A.C.¿ THERAPY SYSTEM HAD A COLLAPSED POWER BUTTON/SWITCH DURING THE REPAIR PROCESS. THE POWER SWITCH WAS REPLACED. THERE IS NO PATIENT OR INJURY ASSOCIATED WITH THIS EVENT.

    Additional Manufacturer Narrative · 1

    DURING THE REPAIR PROCESS, KCI FOUND EVIDENCE THAT THE DEVICE HAD A COLLAPSED POWER SWITCH. THE POWER SWITCH WAS REPLACED. THERE IS NO PATIENT INVOLVEMENT AND THERE WAS NO INJURY REPORTED TO KCI ASSOCIATED WITH THIS EVENT. KCI IS REPORTING THIS EVENT FOUND DURING THE REPAIR PROCESS AS A DEVICE MALFUNCTION THAT HAS THE POTENTIAL TO RESULT IN INJURY IF THE MALFUNCTION WERE TO RECUR.

    Description of Event or Problem · 1

    THIS REPORT SUMMARIZES <NOE> 1 </NOE> MALFUNCTION EVENT. KCI IDENTIFIED THE ACTIV.A.C.¿ ION PROGRESS¿ REMOTE THERAPY MONITORING SYSTEM HAD A COLLAPSED POWER BUTTON/SWITCH DURING THE REPAIR PROCESS AND THE POWER SWITCH WAS REPLACED. THERE IS NO PATIENT OR INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    605250 ACTIV.A.C. THERAPY SYSTEM OMP OMP KINETIC CONCEPTS, INC. WNDACT 00849554001848

    Patients

    Seq Age Sex Outcome Treatment
    1