BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-MR1

    MDR report key: 18334905 · Received December 15, 2023

    Report

    Report Number
    3001421318-2023-12283
    Event Type
    Malfunction
    Date Received
    December 15, 2023
    Date of Event
    July 23, 2022
    Report Date
    August 30, 2024
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    00730002856789
    PMA / PMN Number
    K153046
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT HAS BEEN REOPENED AND REVIEWED ACCORDING TO FDA FORM 483 INSPECTIONAL OBSERVATION EMS #2, EOBS2 FROM THE FDA INSPECTION CONDUCTED BETWEEN JULY 17 TO JULY 21, 2022 AT THE EMS AND BONADUZ SITES. A DETAILED INVESTIGATION WAS PERFORMED BY AN EXPERT FROM THE TECHNICAL SERVICE: SINCE THE COMPLAINT IN QUESTION WAS SUBMITTED TO HAMILTON MEDICAL AG MORE THAN ONE YEAR AGO, NO ATTEMPTS WILL BE PERFORMED TO OBTAIN ADDITIONAL INFORMATION. NO FURTHER INVESTIGATION OR CORRECTION WILL BE PERFORMED EXCEPT THOSE MENTIONED ABOVE. IN FUTURE HAMILTON MEDICAL AG WILL REPORT AN EVENT SIMILAR TO THIS ISSUE AS IT WILL BE DEEMED A REPORTABLE EVENT. THE ALLEGATION IN THIS COMPLAINT WAS CONFIRMED TO BE A COMPLAINT. WITH THIS INVESTIGATION IT HAS BEEN CONFIRMED THAT THE DEVICE FAILED TO MEET ITS SPECIFICATIONS AT THE TIME OF THE EVENT WHILE THE VENTILATOR WAS USED FOR VENTILATION. BASED ON THE DATA FOUND, THE ROOT CAUSE CANNOT BE ESTABLISHED. MOST LIKELY THE ISSUE OCCURRED DUE TO MECHANICAL DAMAGES FROM EXTERNAL INFLUENCES. IN CONSEQUENCE, THE HAMILTON-MR1 DEVICE HAS BEEN REPLACED. THERE WAS NO PATIENT OR USER HARM REPORTED.

    Additional Manufacturer Narrative · 0

    THE COMPLAINT HAS BEEN REOPENED AND REVIEWED ACCORDING TO FDA FORM 483 INSPECTIONAL OBSERVATION EMS #2, EOBS2 FROM THE FDA INSPECTION CONDUCTED BETWEEN JULY 17 TO JULY 21, 2022 AT THE EMS AND BONADUZ SITES. A DETAILED INVESTIGATION WAS PERFORMED BY AN EXPERT FROM THE TECHNICAL SERVICE: SINCE THE COMPLAINT IN QUESTION WAS SUBMITTED TO HAMILTON MEDICAL AG MORE THAN ONE YEAR AGO, NO ATTEMPTS WILL BE PERFORMED TO OBTAIN ADDITIONAL INFORMATION. NO FURTHER INVESTIGATION OR CORRECTION WILL BE PERFORMED EXCEPT THOSE MENTIONED ABOVE. IN FUTURE HAMILTON MEDICAL AG WILL REPORT AN EVENT SIMILAR TO THIS ISSUE AS IT WILL BE DEEMED A REPORTABLE EVENT. THE ALLEGATION IN THIS COMPLAINT WAS CONFIRMED TO BE A COMPLAINT. WITH THIS INVESTIGATION IT HAS BEEN CONFIRMED THAT THE DEVICE FAILED TO MEET ITS SPECIFICATIONS AT THE TIME OF THE EVENT WHILE THE VENTILATOR WAS USED FOR VENTILATION. BASED ON THE DATA FOUND, THE ROOT CAUSE CANNOT BE ESTABLISHED. MOST LIKELY THE ISSUE OCCURRED DUE TO MECHANICAL DAMAGES FROM EXTERNAL INFLUENCES. IN CONSEQUENCE, THE HAMILTON-MR1 DEVICE HAS BEEN REPLACED. THERE WAS NO PATIENT OR USER HARM REPORTED. HAMILTON MEDICAL AG COMPLAINT NUMBER: CER (B)(4). FOLLOW-UP 1 - CORRECTED INFORMATION: UDI RELATED DATA QUALITY UPDATES ONLY. FIELD D4 WAS NOT UPDATED WITH FULL UDI INFORMATION AS REQUESTED SINCE THE DEVICE WAS MANUFACTURED BEFORE 2015 UPDATED FIELDS .

    Description of Event or Problem · 0

    HELLO (B)(6)- ANOTHER INCIDENT OCCURED WITH THIS MR1 VENTILATOR WHILE BEING USED IN TRANSPORT. ESM, CONTROL AND TESLASPY BOARD WERE REPLACED BACK IN APRIL (REF (B)(4) ). THIS ISSUE IS DESCRIBES AS: "THE SCREEN WENT BLACK WITH LINES THROUGH IT AND THE VENTILATOR STOPPED VENTILATING AND WAS SCREAMING A CONTINUOUS ALARM. I HAD TO POWER IT DOWN AS THAT WAS THE ONLY THING THAT GOT IT TO STOP AND NONE OF THE BUTTONS WERE WORKING (I HELD THE POWER AND O2 BUTTONS SIMULTANEOUSLY). THE RT DID TRY TO PUT IT BACK ON THE PATIENT ONCE WE GOT IT POWERED BACK UP AS IT SEEMED TO BE WORKING (AND WEVE HAD THIS HAPPEN IN THE PAST AND HAD IT WORK AGAIN AFTERWARDS) BUT THEY ONLY GOT ABOUT 100FT AND IT DID IT AGAIN. " ESM BOARD HAS BEEN REPLACED 2 OTHER TIMES. CUSTOMER IS RUNNING UNIT NOW AND I AM HAVING THEM MOVE IN TRANSPORT TO SEE IF VIBRATION IS CAUSING ISSUE. UNFORUTUNATELY CUSTOMER(TRAINIED) IS UNABLE AGAIN TO RETRIEVE THE TESLASPY LOGFILES ONCE AGAIN AND BOMIMED TECH IS UNABLE TO BE ON SITE. SITE IS RELUCTANT TO USE VENTILATOR AGAIN AS FAILURES HAVE BEEN MULTIPLE WHILE ON PATIENT. REGARDS (B)(6).

    Description of Event or Problem · 0

    HELLO (B)(6) ANOTHER INCIDENT OCCURED WITH THIS MR1 VENTILATOR WHILE BEING USED IN TRANSPORT. ESM, CONTROL AND TESLASPY BOARD WERE REPLACED BACK IN APRIL (REF CER (B)(4)). THIS ISSUE IS DESCRIBES AS: "THE SCREEN WENT BLACK WITH LINES THROUGH IT AND THE VENTILATOR STOPPED VENTILATING AND WAS SCREAMING A CONTINUOUS ALARM. I HAD TO POWER IT DOWN AS THAT WAS THE ONLY THING THAT GOT IT TO STOP AND NONE OF THE BUTTONS WERE WORKING (I HELD THE POWER AND O2 BUTTONS SIMULTANEOUSLY). THE RT DID TRY TO PUT IT BACK ON THE PATIENT ONCE WE GOT IT POWERED BACK UP AS IT SEEMED TO BE WORKING (AND WE'VE HAD THIS HAPPEN IN THE PAST AND HAD IT WORK AGAIN AFTERWARDS) BUT THEY ONLY GOT ABOUT 100FT AND IT DID IT AGAIN. " ESM BOARD HAS BEEN REPLACED 2 OTHER TIMES. CUSTOMER IS RUNNING UNIT NOW AND I AM HAVING THEM MOVE IN TRANSPORT TO SEE IF VIBRATION IS CAUSING ISSUE. UNFORTUNATELY CUSTOMER(TRAINIED) IS UNABLE AGAIN TO RETRIEVE THE TESLASPY LOGFILES ONCE AGAIN AND BOMIMED TECH IS UNABLE TO BE ON SITE. SITE IS RELUCTANT TO USE VENTILATOR AGAIN AS FAILURES HAVE BEEN MULTIPLE WHILE ON PATIENT. REGARDS (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2298848 HAMILTON-MR1 HAMILTON-MR1 CBK HAMILTON MEDICAL AG 161010 00730002856789

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown