BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITY ACUTE CARE SYSTEM (M540)

    MDR report key: 10669538 · Received October 13, 2020

    Report

    Report Number
    1220063-2020-00013
    Event Type
    Injury
    Date Received
    October 13, 2020
    Date of Event
    September 30, 2020
    Report Date
    November 23, 2020
    Manufacturer
    DRAEGER MEDICAL SYSTEMS, INC
    Product Code
    MHX
    PMA / PMN Number
    K113798
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS PROVIDED STATING THAT THERE WAS NO ALLEGATION OF MALFUNCTION OF A DRAEGER DEVICE IN THIS COMPLAINT. THE CUSTOMER ONLY REQUESTED A LIST OF ALARMS FROM THE EVENT. AFTER REVIEW OF THE LOGS, IT WAS FOUND THAT THE CORRECT ALARMS GENERATED ON THE IACS AS DESIGNED. A LIST OF THE ALARMS , AUDIO PAUSES AND COCKPIT SCREENSHOTS WERE PROVIDED TO THE CUSTOMER. THERE WAS NO DEVICE MALFUNCTION.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS PROVIDED FROM THE CUSTOMER STATING THAT THERE WAS NO ALLEGATION OF MALFUNCTION OF A DRAEGER DEVICE FOR THIS EVENT. THE CUSTOMER REQUESTED AND WAS PROVIDED A LIST OF THE ALARMS PROVIDED AND USER ACTIONS LOGGED DURING THE EVENT. THERE WAS NO DEVICE MALFUNCTION.

    Description of Event or Problem · 0

    ORIGINAL PROBLEM DESCRIPTION: FROM CUSTOMER THERE WAS" CRITICALS ALARMS BETWEEN 6H30 AND 7H45 ON (B)(6) 2020". THESE ALARMS WOULD NOT HAVE BEEN TAKEN BY IACS (ALARMS) OR CARE UNIT STAFF. THE PATIENT WAS RESUSCITATED BY CARDIAC MASSAGE. CARE UNIT STAFF WOULD LIKE TO KNOW IF IACS WARNED CORRECTLY ALL ALARMS IN ORDER TO CHECK IF ALL WAS GOOD ON DETECTION IN IACS. CLARIFICATION OF EVENT DESCRIPTION: A REVIEW OF THE IACS LOGS WAS REQUESTED TO DETERMINE IF ALL ALARMS WERE PROVIDED DURING AN EVENT WHERE THE INVOLVED PATIENT WAS RESUSCITATED. THIS COULD INDICATE AN ALARM FAILURE AND OR A DELAY IN TREATMENT OCCURRED DURING THE EVENT.

    Description of Event or Problem · 0

    A REVIEW OF THE IACS LOGS WAS REQUESTED TO DETERMINE IF ALL ALARMS WERE PROVIDED DURING AN EVENT WHERE THE INVOLVED PATIENT WAS RESUSCITATED. THIS COULD INDICATE AN ALARM FAILURE AND OR A DELAY IN TREATMENT OCCURRED DURING THE EVENT.

    Additional Manufacturer Narrative · 1

    A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THIS INVESTIGATION.

    Description of Event or Problem · 1

    A REVIEW OF THE IACS LOGS WAS REQUESTED TO DETERMINE IF ALL ALARMS WERE PROVIDED DURING AN EVENT WHERE THE INVOLVED PATIENT WAS RESUSCITATED. THIS COULD INDICATE AN ALARM FAILURE AND OR A DELAY IN TREATMENT OCCURRED DURING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1133456 INFINITY ACUTE CARE SYSTEM (M540) PHYSIOLOGIC MONITORING SYSTEM, SINGLE-PATIENT MHX DRAEGER MEDICAL SYSTEMS, INC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention