BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITY ACUTE CARE SYSTEM (M540)

    MDR report key: 11816260 · Received May 13, 2021

    Report

    Report Number
    1220063-2021-00015
    Event Type
    Injury
    Date Received
    May 13, 2021
    Date of Event
    April 16, 2021
    Report Date
    May 31, 2022
    Manufacturer
    DRAEGER MEDICAL SYSTEMS, INC
    Product Code
    MHX
    PMA / PMN Number
    K113798
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    FOR THIS CASE, IT WAS CLARIFIED THAT 2 ISSUES WERE BEING REPORTED. 1 ¿ THE PULSE TONE VOLUME BECAME QUIETER AS THE SATURATION FELL DURING THE EVENT (COULD NO LONGER BE HEARD WHEN SATURATION WAS AT 74%) AND 2 - NO LOW SPO2 ALARM WAS PROVIDED DURING THE EVENT. ADDITIONALLY, IT WAS CONFIRMED THAT THERE WAS NO ADVERSE PATIENT IMPACT REPORTED. ISSUE 1 - REVIEW OF THE DEVICE LOGS SHOW THAT A LOW SPO2 ALARM WAS PROVIDED DURING THE TIME OF THE REPORTED EVENT. (B)(6) 2021 8:50:35 TD TD MESSAGE TD TD ISSUE 5462 'SPO2 85' MEDIUM (B)(6) 2021 8:50:35 TD TD ALARM TD TD PID=PI_SO2_SO2 GRADE=MEDIUM TYPE=NON-LATCH VALUE=82 EVENT CODE=ACTIVE ARCHIVE=STORE MBR=5462. HOWEVER, THE CUSTOMER REPORTED THAT NO SPO2 ALARM WAS PROVIDED. IT WAS LATER CLARIFIED THAT INSTEAD NO RED ALARM FOR SPO2 DESATURATION GENERATED. AFTER REVIEW OF A VIDEO PROVIDED FROM THE SITE OF THE M540, IT WAS FOUND THAT ALTHOUGH THE DESAT LIMITS WERE BREACHED, NO ALARM GENERATED FOR SPO2 DESAT. FROM THE VIDEO, IT WAS FOUND THIS WAS BECAUSE THE SPO2 DESAT ALARM WAS DISABLED. THE DEFAULT SETTING FOR THE SPO2 DESATURATION ALARM FOR ADULT AND PEDIATRIC PATIENT TYPES IS OFF. THIS INFORMATION WAS PROVIDED TO THE CUSTOMER. THE DEVICE WAS EVALUATED ON SITE BY A DRAEGER SERVICE TECHNICIAN WITH NO MALFUNCTIONS IDENTIFIED AS ALARMS GENERATED FOR BOTH LOW SPO2 AND SPO2 DESAT WHEN EXPECTED. THERE WAS NO DEVICE MALFUNCTION. ISSUE 2 - BASED ON A PREVIOUS SIMILAR INVESTIGATION FROM THE SAME SITE, ROOT CAUSE OF THE LOW PULSE TONE VOLUME COULD BE ISOLATED TO A FAILURE OF THE AUDIO AMPLIFIER IC OF THE CITED DEVICES. A CAPA INVESTIGATION HAS BEEN OPENED TO FURTHER INVESTIGATE THIS ISSUE. NOTE THAT THOUGH THE USER MAY LOSE THE ABILITY TO HEAR THE PULSE TONES GENERATED THROUGH THE SPO2 SIGNAL AT LOW SATURATIONS, THIS IS NOT A PATIENT ALARM. THIS ISSUE DOES NOT IMPACT SPO2 ALARM FUNCTION.

    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 H3. - NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT: THE PULSE TONE OF THE SATURATION BECOMES QUIETER AND QUIETER AS THE SATURATION DECREASES AND COULD NO LONGER BE HEARD DURING THE INCIDENT (SATURATION WAS AT 74%). AFTERWARDS, THE OXYGEN DOSAGE WAS INCREASED, WHICH INCREASED THE BLOOD PRESSURE AND WHEN THE SATURATION WAS AGAIN AT APPROX. 82%, THE PULSE TONE WAS HEARABLE AGAIN. THE DETERIORATION WAS NOT APPARENT BECAUSE THE MONITOR DID NOT REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT: THE PULSE TONE OF THE SATURATION BECOMES QUIETER AND QUIETER AS THE SATURATION DECREASES AND COULD NO LONGER BE HEARD DURING THE INCIDENT (SATURATION WAS AT 74%). AFTERWARDS, THE OXYGEN DOSAGE WAS INCREASED, WHICH INCREASED THE BLOOD PRESSURE AND WHEN THE SATURATION WAS AGAIN AT APPROX. 82%, THE PULSE TONE WAS HEARABLE AGAIN. THE DETERIORATION WAS NOT APPARENT BECAUSE THE MONITOR DID NOT REPORT.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: THE PULSE TONE OF THE SATURATION BECOMES QUIETER AND QUIETER AS THE SATURATION DECREASES AND COULD NO LONGER BE HEARD DURING THE INCIDENT (SATURATION WAS AT 74%). AFTERWARDS, THE OXYGEN DOSAGE WAS INCREASED, WHICH INCREASED THE BLOOD PRESSURE AND WHEN THE SATURATION WAS AGAIN AT APPROX. 82%, THE PULSE TONE WAS HEARABLE AGAIN. THE DETERIORATION WAS NOT APPARENT BECAUSE THE MONITOR DID NOT REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    719386 INFINITY ACUTE CARE SYSTEM (M540) PHYSIOLOGIC MONITORING SYSTEM, SINGLE-PATIENT MHX DRAEGER MEDICAL SYSTEMS, INC MS20401

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Life Threatening