BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOPOD

    MDR report key: 20190075 · Received September 11, 2024

    Report

    Report Number
    1220063-2024-00104
    Event Type
    Malfunction
    Date Received
    September 11, 2024
    Report Date
    November 26, 2024
    Manufacturer
    DRAEGER MEDICAL SYSTEMS, INC
    Product Code
    MHX
    UDI-DI
    04049098003667
    PMA / PMN Number
    K070566
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO DRAEGER FOR EVALUATION. DURING TESTING, ENGINEERING WAS ABLE TO CONFIRM THAT THE MAIN PRINTED CIRCUIT BOARD ASSEMBLY (PCBA) FROM THE CITED POD WAS THE CAUSE OF THE INACCURATE READINGS. THE PCBA WAS REPLACED AND DRAEGER PERFORMED TESTING OF THE DEVICE TO CONFIRM FULL FUNCTIONALITY OF THE POD. SERVICE PROVIDED THE QUAD HEMO MPOD TO LOGISTICS FOR CUSTOMER RETURN AND CLINICAL USE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED INACCURATE READINGS. THE ANESTHESIA ASSISTANT REPORTED THAT THE MPOD QUAD HEMO GAVE "INACCURATE" ARTERIAL VALUES AND REQUIRED RE-ZEROING TO GET ACCURATE VALUES. THE USERS RE-ZEROED THE QUA HEMO THREE TIMES, AND THEN REPLACED IT WITH ANOTHER DEVICE. ONCE THE USERS SWITCHED TO THE OTHER QUAD HEMO, THE HEMO GAVE THE EXPECTED PRESSURES. THE BIOMED AT THE CUSTOMER SITE HAD TESTED THE DEVICE ON AN EDWARDS IBP SIMULATOR WITH NO MALFUNCTION FOUND AND RETURNED IT TO SERVICE. THE MALFUNCTION OCCURRED AGAIN ON JUNE 30TH. THE CUSTOMER BIOMED TESTED AGAIN AND FOUND THAT THE PRESSURES WOULD NOT CHANGE FROM 0MMHG INTERMITTENTLY, WHEN IT WAS THEN REPORTED TO DRAEGER. NO ADVERSE PATIENT IMPACT OR PATIENT DEATH WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED INACCURATE READINGS. THE ANESTHESIA ASSISTANT REPORTED THAT THE MPOD QUAD HEMO GAVE "INACCURATE" ARTERIAL VALUES AND REQUIRED RE-ZEROING TO GET ACCURATE VALUES. THE USERS RE-ZEROED THE QUA HEMO THREE TIMES, AND THEN REPLACED IT WITH ANOTHER DEVICE. ONCE THE USERS SWITCHED TO THE OTHER QUAD HEMO, THE HEMO GAVE THE EXPECTED PRESSURES. THE BIOMED AT THE CUSTOMER SITE HAD TESTED THE DEVICE ON AN EDWARDS IBP SIMULATOR WITH NO MALFUNCTION FOUND AND RETURNED IT TO SERVICE. THE MALFUNCTION OCCURRED AGAIN ON JUNE 30TH. THE CUSTOMER BIOMED TESTED AGAIN, AND FOUND THAT THE PRESSURES WOULD NOT CHANGE FROM 0MMHG INTERMITTENTLY, WHEN IT WAS THEN REPORTED TO DRAEGER. NO ADVERSE PATIENT IMPACT OR PATIENT DEATH WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    539075 HEMOPOD SIMULATORS, INVASIVE BLOOD PRESSURE MHX DRAEGER MEDICAL SYSTEMS, INC 04049098003667

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown