BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-T1

    MDR report key: 18133761 · Received November 14, 2023

    Report

    Report Number
    3001421318-2023-12972
    Event Type
    Malfunction
    Date Received
    November 14, 2023
    Date of Event
    June 27, 2022
    Report Date
    August 9, 2024
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002806091
    PMA / PMN Number
    K181216
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    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 ALMOST 2 YEARS 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 IN USE. THE ROOT CAUSE WAS DETERMINED TO BE UNPROPERLY CONNECTED FFC PRESSURE SENSOR BOARD <-> CONTROL BOARD IN CONSEQUENCE CORRECTION AFTER INVESTIGATION TO RESEAT AND RETACKED DOWN LOOSE FFC FROM DISPLAY CORRECTED THE ISSUE. THERE WAS NO PATIENT OR USER HARM.

    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 ALMOST 2 YEARS 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 IN USE. THE ROOT CAUSE WAS DETERMINED TO BE UNPROPERLY CONNECTED FFC PRESSURE SENSOR BOARD CONTROL BOARD IN CONSEQUENCE CORRECTION AFTER INVESTIGATION TO RESEAT AND RETACKED DOWN LOOSE FFC FROM DISPLAY CORRECTED THE ISSUE. THERE WAS NO PATIENT OR USER HARM. HAMILTON MEDICAL AG COMPLAINT NUMBER: CER (B)(4). FOLLOW-UP 1 - CORRECTED INFORMATION: UDI RELATED DATA QUALITY UPDATES ONLY FIELD D4 WAS UPDATED WITH FULL UDI INFORMATION AS REQUESTED. UPDATED FIELDS.

    Description of Event or Problem · 0

    ON JUN 29, 2022, AT 5:02 PM, (B)(4) WROTE: (B)(6), PLEASE SEE THE ATTACHED LOGS THAT DAVE HAD ME DOWNLOAD ON A GRAY T1 THAT BELONGS TO UPMC STATMEDEVAC. THEY ARE CONCERNED THAT THEY ARE HAVING ISSUES WITH THE "GRAY VERSION" VS THE "RED VERSION". THEY HAVE 40 PLUS RED ONES AND 5 GRAY T1S. THIS DEVICE HAD A "SAFETY VALVE " CONDITION AND WHITE SCREEN ON A PATIENT DURING A TRANSPORT. NO ADVERSE PATIENT REACTIONS, BUT LOTS OF CONCERNS. CAN THIS BE REPAIRED IN THE FIELD ? THEY SHARED THIS DOCUMENT TO SHOW THE OTHER DEVICES. WE SHOULD HAVE RGA ON THE UNITS BELOW. HAMILTON GRAY T1 VENTILATOR 509476 2/23/2021 REPAIR TECHNICAL EVENT 232035 WHILE HFNC (B)(4) PENDING RMA HAVE A GREAT DAY! KIND REGARDS, (B)(4) RRT-NPS,CPFT, RCP ACCOUNT MANAGER HAMILTON MEDICAL, INC. 4655 AIRCENTER CIRCLE RENO, NV 89502 UNITED STATES PHONE: (800) 426 6331, EXT. 7738 CELL: (B)(6).

    Description of Event or Problem · 0

    ON (B)(6) 2022, AT 5:02 PM,(B)(6) WROTE: DAN, PLEASE SEE THE ATTACHED LOGS THAT(B)(6) HAD ME DOWNLOAD ON A GRAY T1 THAT BELONGS TO (B)(6). THEY ARE CONCERNED THAT THEY ARE HAVING ISSUES WITH THE "GRAY VERSION" VS THE "RED VERSION". THEY HAVE 40 PLUS RED ONES AND 5 GRAY T1S. THIS DEVICE HAD A "SAFETY VALVE " CONDITION AND WHITE SCREEN ON A PATIENT DURING A TRANSPORT. NO ADVERSE PATIENT REACTIONS, BUT LOTS OF CONCERNS. CAN THIS BE REPAIRED IN THE FIELD ? THEY SHARED THIS DOCUMENT TO SHOW THE OTHER DEVICES. WE SHOULD HAVE RGA ON THE UNITS BELOW. HAMILTON GRAY T1 VENTILATOR 509476 2/23/2021 REPAIR TECHNICAL EVENT 232035 WHILE HFNC (B)(6) 18050PG 507684 10/21/2021 DOCUMENTATION ALARM ON STARTUP (B)(6) 20095PG 505676 ON (B)(6) 2021 DOCUMENTATION RELEASE VALVE DEFECTIVE MESSAGE (B)(6) 20176PG 507684 11/29/2021 REPAIR FAULTY EXHALATION VALVE, NO PEEP DETECTED (B)(6) 20444PG 509476 12/11/2021 REPAIR NOT PASSING FLOW SENSOR TEST (B)(6) 20750PG 501879 12/20/2021 PREVENTATIVE MAINTENANCE PM (B)(6) 21689PG 505676 1/12/2022 REPAIR ERROR CODE 232035 (B)(6) 21252PG 505676 6/11/2022 REPAIR ERROR CODE 232035 (B)(6) 22237PG 509476 6/11/2022 REPAIR RELEASE VALVE DEFECTIVE MESSAGE (B)(6) 22237PG 503361 6/28/2022 REPAIR UNABLE TO PASS FLOW SENSOR, THEN "EMERGENCY VENTILATION" MESSAGE (B)(6) PENDING RMA HAVE A GREAT DAY! KIND REGARDS, (B)(6) RRT-NPS, CPFT, RCP ACCOUNT MANAGER HAMILTON MEDICAL, INC. 4655 AIRCENTER CIRCLE RENO, NV 89502 UNITED STATES PHONE:(B)(6) EXT. 7738 CELL: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2028208 HAMILTON-T1 HAMILTON-T1 CBK HAMILTON MEDICAL AG 161009 07630002806091

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown