BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAVINA 300

    MDR report key: 11783286 · Received May 6, 2021

    Report

    Report Number
    9611500-2021-00198
    Event Type
    Malfunction
    Date Received
    May 6, 2021
    Date of Event
    April 12, 2021
    Report Date
    May 26, 2022
    Manufacturer
    DRÄGERWERK AG & CO. KGAA
    Product Code
    CBK
    UDI-DI
    04048675251422
    PMA / PMN Number
    K180779
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DUE TO A TECHNICAL ISSUE WITH OUR INTERNAL EMDR SYSTEM WE SUBMITTED FOR THE FORM FDA 3500A AN INCORRECT VALUE FOR THE FIELD.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION WAS CARRIED OUT BASED ON THE DESCRIPTION OF THE EVENT, CONSIDERING THE ENTRIES STILL AVAILABLE IN THE LOGBOOK. THE DAY OF THE EVENT WAS NO LONGER SHOWN IN THE LOGBOOK; THE DEVICE WAS STILL IN USE AFTER THE EVENT AND OLDER ENTRIES WERE OVERWRITTEN. BASED ON THE INVESTIGATION, A PROBLEM WITH THE INTERNAL BATTERY COULD BE VERIFIED; A FAULTY OR HEAVILY AGED INTERNAL BATTERY MAY HAVE LED TO THE DESCRIBED DEVICE FAILURE DURING TRANSPORT. DUE TO THE MISSING ENTRIES OF THE LOGBOOK FOR THE DAY OF THE EVENT, IT COULD NOT BE CONCLUSIVELY CLARIFIED WHETHER THE DEVICE ALERTED THE REMAINING CAPACITY OF THE INTERNAL BATTERY AS SPECIFIED BEFORE THE FAILURE OCCURRED. HOWEVER, THE LOGBOOK SUGGESTS THAT - CONTRARY TO WHAT WAS REPORTED - THERE WAS AN ALARM OF THE FAILURE OF THE INTERNAL BATTERY BY MEANS OF A POWER FAILURE ALARM. THE AUDIBLE POWER FAILURE ALARM OF AT LEAST 2 MINUTES IS GENERATED VIA THE REDUNDANT BUZZER USING A CHARGED CAPACITOR. SINCE THE DEVICE WAS STILL IN USE AFTER THE DAY OF THE EVENT AND THE DEVICE CHECK WAS ALSO SUCCESSFULLY RUN AFTERWARDS, THE ACOUSTIC ALARM MUST HAVE WORKED. THE FUNCTION OF THE BUZZER IS CHECKED AS PART OF THE DEVICE CHECK. IN THE CURRENT EVENT THE INTERNAL BATTERY HAS TO BE REPLACED. THE DEVICE SHOULD ALSO BE EQUIPPED WITH AN EXTERNAL BATTERY THAT PROVIDES ADDITIONAL OPERATING TIME FOR INTRA-HOSPITAL TRANSPORT AND PREVENTS PREMATURE WEAR OF THE INTERNAL BATTERY. THE NUMBER OF SIMILAR CASES, RELATED TO THE SAME ROOT CAUSE, IS WITHIN THE EXPECTED RANGE OF THE RESPECTIVE RISK ASSESSMENT AND THUS ACCEPTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE SWITCHED OFF ITSELF DURING TRANSPORT FROM THE CARDIAC CATHETER LABORATORY (TRANSLATION OF: HKL / HERZKATHEDERLABOR) TO THE ICU. THE DEVICE HAD BEEN CONNECTED TO OXYGEN AND POWER SOURCE OF THE SUPPLY UNIT BEFORE. THE PROCEDURE AT THE CARDIAC CATHETER LABORATORY LASTED FOR 60 MINUTES. THERE WERE NO PATIENT HEALTH CONSEQUENCES REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE SWITCHED OFF ITSELF DURING TRANSPORT FROM THE CARDIAC CATHETER LABORATORY (TRANSLATION OF: HKL / HERZKATHEDERLABOR) TO THE ICU. THE DEVICE HAD BEEN CONNECTED TO OXYGEN AND POWER SOURCE OF THE SUPPLY UNIT BEFORE. THE PROCEDURE AT THE CARDIAC CATHETER LABORATORY LASTED FOR 60 MINUTES. THERE WERE NO PATIENT HEALTH CONSEQUENCES REPORTED.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION HAS JUST STARTED; RESULTS WILL BE PROVIDED IN A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE SWITCHED OFF ITSELF DURING TRANSPORT FROM THE CARDIAC CATHETER LABORATORY (TRANSLATION OF: (B)(6)) TO THE ICU. THE DEVICE HAD BEEN CONNECTED TO OXYGEN AND POWER SOURCE OF THE SUPPLY UNIT BEFORE. THE PROCEDURE AT THE CARDIAC CATHETER LABORATORY LASTED FOR 60 MINUTES. THERE WERE NO PATIENT HEALTH CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684291 SAVINA 300 VENTILATORS, INTENSIVE CARE CBK DRÄGERWERK AG & CO. KGAA NA NA 04048675251422

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown NA.| NA.| NA.