BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    ACTIV.A.C. THERAPY SYSTEM

    MDR report key: 10141596 · Received June 11, 2020

    Report

    Report Number
    3009897021-2020-00230
    Event Type
    Malfunction
    Date Received
    June 11, 2020
    Date of Event
    February 20, 2020
    Report Date
    September 29, 2020
    Manufacturer
    KINETIC CONCEPTS, INC.
    Product Code
    OMP
    UDI-DI
    00878237008188
    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-3009897021-2020-00230 SUBMITTED ON11-JUN-2020 NOTED THAT IT WAS A SUMMARY OF 41 EVENTS 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 D4 UNIQUE IDENTIFIER (UDI) # WAS UPDATED TO REFLECT THE FULL UDI NUMBER. SECTION B3 DATE OF EVENT AND G4 DATE RECEIVED BY MANUFACTURER NOTED 13-FEB-2020. CORRECTION SECTION B3 DATE OF EVENT AND G3 DATE RECEIVED BY MANUFACTURER 20-FEB-2020. 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 DEVICES EACH HAD A COLLAPSED DOME. THE POWER SWITCH WAS REPLACED. THERE IS NO PATIENT INVOLVEMENT AND THERE ARE NO INJURIES REPORTED TO KCI ASSOCIATED WITH THESE EVENTS. KCI IS REPORTING THESE EVENTS FOUND DURING THE REPAIR PROCESS AS DEVICE MALFUNCTIONS THAT HAVE THE POTENTIAL TO RESULT IN INJURY IF THE MALFUNCTION WERE TO RECUR. ADDITIONAL DEVICE INFORMATION FOR MALFUNCTION EVENTS SUMMARIZED IN THIS REPORT: DATE OF EVENT: THE MALFUNCTION EVENTS OCCURRED BETWEEN (B)(6) 2020 AND (B)(6) 2020. ADDITIONAL SERIAL NUMBERS INCLUDED IN THIS SUMMARY REPORT: (B)(4). ADDITIONAL UNIQUE IDENTIFIER (UDI) #: UDI NUMBERS FOR AFFECTED SERIAL NUMBERS INCLUDED IN THIS SUMMARY REPORT: (B)(4). DATE RECEIVED BY MANUFACTURER: KCI IDENTIFIED THE MALFUNCTION EVENTS BETWEEN 13-FEB-2020 AND 06-MAY-2020. DEVICE MANUFACTURE DATE: THE DEVICES INCLUDED IN THIS SUMMARY REPORT WERE MANUFACTURED BETWEEN 25-JUNE-2007 THROUGH 23-MAR-2018.

    Description of Event or Problem · 1

    THIS REPORT SUMMARIZES <NOE> 41 </NOE> MALFUNCTION EVENTS. KCI IDENTIFIED THE ACTIV.A.C.¿ THERAPY SYSTEMS HAD COLLAPSED POWER BUTTONS/SWITCHES DURING THE REPAIR PROCESS AND THE POWER SWITCHES WERE REPLACED. THERE ARE NO PATIENTS OR INJURIES ASSOCIATED WITH THESE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    609945 ACTIV.A.C. THERAPY SYSTEM OMP OMP KINETIC CONCEPTS, INC. WNDACT 00878237008188

    Patients

    Seq Age Sex Outcome Treatment
    1