HAMILTON-T1
Report
- Report Number
- 3001421318-2024-01504
- Event Type
- Malfunction
- Date Received
- June 24, 2024
- Date of Event
- May 18, 2024
- Report Date
- November 3, 2025
- Manufacturer
- HAMILTON MEDICAL AG
- Product Code
- CBK
- UDI-DI
- 07630002806091
- PMA / PMN Number
- K181216
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NV, US
- Reporter Occupation
- 003
Narratives
HAMILTON MEDICAL AG COMPLAINT NUMBER: (B)(4) FOLLOW-UP 1 - CORRECTED INFORMATION: UDI RELATED DATA QUALITY UPDATES ONLY FIELD D4 WAS UPDATED WITH FULL UDI INFORMATION. UPDATED FIELDS.
HAMILTON MEDICAL AG COMPLAINT NUMBER: (B)(4). FOLLOW-UP 1 - CORRECTED INFORMATION: UDI RELATED DATA QUALITY UPDATES ONLY. FIELD D4 WAS UPDATED WITH FULL UDI INFORMATION. UPDATED FIELDS: B4, D1, D4, G6, H2, H4, H11. FOLLOW-UP 2 - ADDITIONAL INFORMATION: THE ENTRY FIELDS B4, G6, H2, H3, H6 AND H11 HAVE BEEN UPDATED. DURING START UP THE VENTILATOR ALARMS WITHOUT VISIBLE ALARMS OR LOGGING TFS IN THE EVENT LOG (BOOT LOGO, STUCK ON LOADING). NO PATIENT INVOLVED. CONSEQUENTLY, THE EVENT DID NOT CAUSE OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY. IF A VENTILATOR FAILS TO START UP, IT PREVENTS THE EXECUTION OF MANDATORY SELF-TESTS AND, AS A RESULT, WILL NOT BE CLEARED FOR PATIENT USE. THIS MEANS THAT A STARTUP FAILURE DOES NOT POSE AN IMMEDIATE RISK TO A PATIENT, AS THE DEVICE WOULD NEVER BE PUT INTO OPERATION WITHOUT PASSING THE REQUIRED CHECKS. THE FAILURE IS CONTAINED WITHIN THE PRE-USE VERIFICATION PROCESS, ENSURING THAT NO FAULTY DEVICE IS USED FOR PATIENT CARE. THERE IS NO INFORMATION THAT REASONABLY SUGGEST THAT THE DEVICE HAS MALFUNCTIONED AND THAT THE DEVICE OR A SIMILAR DEVICE WOULD BE LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR. THEREFORE, BASED ON THIS INFORMATION, THE EVENT IS ASSESSED AS NO LONGER REPORTABLE AND THE EVENT CAN BE CLOSED WITH THIS FOLLOW UP REPORT.
THE FOLLOWING HAS BEEN REPORTED TO HAMILTON MEDICAL AG ON 24 MAY 2024. IT WAS REPORTED BY HAMILTON MEDICAL INC, THAT ON (B)(6) 2024, DURING START UP PHASE, A HAMILTON-T1 (SN (B)(6) SHOWED A STARTUP FAILED. VENTILATOR ALARMS WITHOUT VISIBLE ALARMS OR LOGGING TFS IN THE EVENTLOG (BOOT LOGO, STUCK ON LOADING) VENTILATOR WOULD NOT COMPLETE THE BOOT PROCESS. FROZE PART WAY THROUGH AND EVENTUALLY ALARMED. CONTINUOUS AUDIBLE ALARM, BOOT LOGO DISPLAYED, NO VISIBLE ALARM IN LOG FILE. AS IMMEDIATE CORRECTIVE ACTION, REPLACEMENT OF THE ESM. DEVICE FUNCTIONS OK AND PASSED ALL TESTS. NO PATIENT INVOLVED. AS PER PRELIMINARY INVESTIGATION, THE DELIVERED FLOW QVENT/QAW DOES NOT MATCH WITH THE EXTERNAL MEASUREMENT. POSSIBLE CORRECTION THAT MIGHT BE CONSIDERED ARE AS FOLLOW: IF POSSIBLE, CHECK AND REPORT VOLTAGES ON CONTROL BOARD WHEN THE SELFT TEST FAILS. CHECK CABLE CONNECTION, CHECK THAT THE ESM IS PROPERLEY SITTED, CHECK THAT THE SD CARD IS PROPERLY INSERTED, REPLACE ESM. AS WORKAROUND: RESTART THE VENTILATOR. ACCORDING TO THE AVAILABLE INFORMATION, THERE IS NO INDICATION THAT THE COMPLAINT LEAD TO DEATH, INJURY OR SERIOUS DETERIORATION OF THE HEALTH OF THE PATIENT, USER OR THIRD-PARTY.
THE FOLLOWING HAS BEEN REPORTED TO HAMILTON MEDICAL AG ON 24 MAY 2024 IT WAS REPORTED BY HAMILTON MEDICAL INC, THAT ON (B)(6) 2024, DURING START UP PHASE, A HAMILTON-T1 (SN (B)(6) SHOWED A STARTUP FAILED . VENTILATOR ALARMS WITHOUT VISIBLE ALARMS OR LOGGING TFS IN THE EVENTLOG (BOOT LOGO, STUCK ON LOADING) VENTILATOR WOULD NOT COMPLETE THE BOOT PROCESS. FROZE PART WAY THROUGH AND EVENTUALLY ALARMED. CONTINUOUS AUDIBLE ALARM, BOOT LOGO DISPLAYED, NO VISIBLE ALARM IN LOG FILE AS IMMEDIATE CORRECTIVE ACTION, REPLACEMENT OF THE ESM. DEVICE FUNCTIONS OK AND PASSED ALL TESTS. NO PATIENT INVOLVED. AS PER PRELIMINARY INVESTIGATION, THE DELIVERED FLOW QVENT/QAW DOES NOT MATCH WITH THE EXTERNAL MEASUREMENT. POSSIBLE CORRECTION THAT MIGHT BE CONSIDERED ARE AS FOLLOW: IF POSSIBLE CHECK AND REPORT VOLTAGES ON CONTROL BOARD WHEN THE SELFT TEST FAILS. CHECK CABLE CONNECTION CHECK THAT THE ESM IS PROPERLEY SITTED CHECK THAT THE SD CARD IS PROPERLY INSERTED REPLACE ESM AS WORKAROUND: RESTART THE VENTILATOR ACCORDING TO THE AVAILABLE INFORMATION, THERE IS NO INDICATION THAT THE COMPLAINT LEAD TO DEATH, INJURY OR SERIOUS DETERIORATION OF THE HEALTH OF THE PATIENT, USER OR THIRD-PARTY.
THE FOLLOWING HAS BEEN REPORTED TO HAMILTON MEDICAL AG ON 24 MAY 2024. IT WAS REPORTED BY HAMILTON MEDICAL INC, THAT ON (B)(6) 2024, DURING START UP PHASE, A HAMILTON-T1 (SN (B)(6)) SHOWED A STARTUP FAILED. VENTILATOR ALARMS WITHOUT VISIBLE ALARMS OR LOGGING TFS IN THE EVENTLOG (BOOT LOGO, STUCK ON LOADING) VENTILATOR WOULD NOT COMPLETE THE BOOT PROCESS. FROZE PART WAY THROUGH AND EVENTUALLY ALARMED. CONTINUOUS AUDIBLE ALARM, BOOT LOGO DISPLAYED, NO VISIBLE ALARM IN LOG FILE. AS IMMEDIATE CORRECTIVE ACTION, REPLACEMENT OF THE ESM. DEVICE FUNCTIONS OK AND PASSED ALL TESTS. NO PATIENT INVOLVED. AS PER PRELIMINARY INVESTIGATION, THE DELIVERED FLOW QVENT/QAW DOES NOT MATCH WITH THE EXTERNAL MEASUREMENT. POSSIBLE CORRECTION THAT MIGHT BE CONSIDERED ARE AS FOLLOW: - IF POSSIBLE CHECK AND REPORT VOLTAGES ON CONTROL BOARD WHEN THE SELFT TEST FAILS. - CHECK CABLE CONNECTION - CHECK THAT THE ESM IS PROPERLEY SITTED - CHECK THAT THE SD CARD IS PROPERLY INSERTED - REPLACE ESM. AS WORKAROUND: RESTART THE VENTILATOR. ACCORDING TO THE AVAILABLE INFORMATION, THERE IS NO INDICATION THAT THE COMPLAINT LEAD TO DEATH, INJURY OR SERIOUS DETERIORATION OF THE HEALTH OF THE PATIENT, USER OR THIRD-PARTY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1068403 | HAMILTON-T1 | HAMILTON-T1 | CBK | HAMILTON MEDICAL AG | 161009 | 07630002806091 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |