HAMILTON-MR1
Report
- Report Number
- 3001421318-2024-00545
- Event Type
- Death
- Date Received
- March 20, 2024
- Date of Event
- February 29, 2024
- Report Date
- November 11, 2024
- Manufacturer
- HAMILTON MEDICAL AG
- Product Code
- CBK
- UDI-DI
- 07630002800761
- PMA / PMN Number
- K153046
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
HAMILTON MEDICAL AG CASE NUMBER IS (B)(4). HAMILTON MEDICAL AG COMPLAINT NUMBER: (B)(4). FOLLOW-UP 1 - INVESTIGATION OUTCOME: A DETAILED INVESTIGATION WAS PERFORMED BY AN EXPERT FROM THE TECHNICAL SERVICE: THE ALLEGATION IN THIS COMPLAINT WAS CONFIRMED TO BE A COMPLAINT AS A MALFUNCTION OF THE DEVICE COULD BE IDENTIFIED. WITH THIS INVESTIGATION IT HAS BEEN CONFIRMED THAT THE DEVICE FAILED TO MEET ITS SPECIFICATIONS AT THE TIME OF THE EVENT WHEN THE VENTILATOR WAS USED. THIS EVENT HAS BEEN ASSESSED AS REPORTABLE. PATIENT'S DEATH WAS REPORTED DURING VENTILATION OF THE HAMILTON-MR1 DEVICE. THE EXACT CONTEXT OF THE DEATH WAS NOT INDICATED, E.G. PRIOR OR DURING AN MRI. NEITHER DELAY IN TREATMENT NOR HARM TO USER OR THIRD PARTY HAS BEEN REPORTED. HOWEVER PATIENT HARM IS REPORTED AS THE PATIENT PASSED AWAY DURING THE USE OF THE VENTILATOR. THE MOST PROBABLE ROOT CAUSE WAS IDENTIFIED AS TECHNICAL PROBLEMS WITH THE OXYGEN SENSOR, AFFECTING OXYGEN SUPPLY AND OXYGEN FLOW MEASUREMENT, WHICH OCCURRED IN CONJUNCTION WITH A LACK OF PROPER DEVICE MAINTENANCE AND CALIBRATION, DESPITE THE SPORADIC OCCURRENCES OF TECHNICAL ALARMS SINCE SEPTEMBER 2022. THE CORRECTION NEEDS TO CONSIST IN A PROPER DEVICE MAINTENANCE AND CALIBRATION, IN PARTICULAR OF THE OXYGEN SUPPLY AND OXYGEN FLOW MEASUREMENT AND AN UPGRADE OF VENTILATOR''S SOFTWARE FROM 2.2.10 VERSION TO 3.0.3. THE TECHNICAL PROBLEM HAS PREVIOUSLY BEEN INVESTIGATED IS WITHIN THE SCOPE OF ECO M1277, WHICH LEAD SUBSEQUENTLY TO A TECHNICAL SOLUTION DESCRIBED IN CAR M2746. NEVERTHELESS, THE FAILURES OF DEVICES IN THE MARKET ARE MONITORED CONSTANTLY AND IF THE FAILURE RATE WAS TO INCREASE, A CAPA WILL BE CONSIDERED. HAMILTON MEDICAL AG COMPLAINT NUMBER: (B)(4). FOLLOW-UP 2 - CORRECTED INFORMATION: **UDI RELATED DATA QUALITY UPDATES ONLY** FIELD D4 WAS UPDATED WITH FULL UDI INFORMATION. UPDATED FIELDS: B4, D1, D3, D4, G6, H2, H4, H6, H11.
HAMILTON MEDICAL AG CASE NUMBER IS (B)(4). INVESTIGATION ONGOING.
A DETAILED INVESTIGATION WAS PERFORMED BY AN EXPERT FROM THE TECHNICAL SERVICE: THE ALLEGATION IN THIS COMPLAINT WAS CONFIRMED TO BE A COMPLAINT AS A MALFUNCTION OF THE DEVICE COULD BE IDENTIFIED. WITH THIS INVESTIGATION IT HAS BEEN CONFIRMED THAT THE DEVICE FAILED TO MEET ITS SPECIFICATIONS AT THE TIME OF THE EVENT WHEN THE VENTILATOR WAS USED. THIS EVENT HAS BEEN ASSESSED AS REPORTABLE. PATIENT'S DEATH WAS REPORTED DURING VENTILATION OF THE HAMILTON-MR1 DEVICE. THE EXACT CONTEXT OF THE DEATH WAS NOT INDICATED, E.G. PRIOR OR DURING AN MRI. NEITHER DELAY IN TREATMENT NOR HARM TO USER OR THIRD PARTY HAS BEEN REPORTED. HOWEVER PATIENT HARM IS REPORTED AS THE PATIENT PASSED AWAY DURING THE USE OF THE VENTILATOR. THE MOST PROBABLE ROOT CAUSE WAS IDENTIFIED AS TECHNICAL PROBLEMS WITH THE OXYGEN SENSOR, AFFECTING OXYGEN SUPPLY AND OXYGEN FLOW MEASUREMENT, WHICH OCCURRED IN CONJUNCTION WITH A LACK OF PROPER DEVICE MAINTENANCE AND CALIBRATION, DESPITE THE SPORADIC OCCURRENCES OF TECHNICAL ALARMS SINCE SEPTEMBER 2022. THE CORRECTION NEEDS TO CONSIST IN A PROPER DEVICE MAINTENANCE AND CALIBRATION, IN PARTICULAR OF THE OXYGEN SUPPLY AND OXYGEN FLOW MEASUREMENT AND AN UPGRADE OF VENTILATOR''S SOFTWARE FROM 2.2.10 VERSION TO 3.0.3. THE TECHNICAL PROBLEM HAS PREVIOUSLY BEEN INVESTIGATED IS WITHIN THE SCOPE OF ECO M1277, WHICH LEAD SUBSEQUENTLY TO A TECHNICAL SOLUTION DESCRIBED IN CAR M2746. NEVERTHELESS, THE FAILURES OF DEVICES IN THE MARKET ARE MONITORED CONSTANTLY AND IF THE FAILURE RATE WAS TO INCREASE, A CAPA WILL BE CONSIDERED.
THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: THIS EVENT WITH DATE OF 29.02.2024 (EXACT TIME WAS NOT PROVIDED) HAS BEEN ASSESSED AS REPORTABLE. THE PATIENT DIED WHILE BEING VENTILATED WITH A HAMILTON-MR1 VENTILATOR DEVICE. PLEASE NOTE THAT THE HAMILTON-MR1 VENTILATOR IS USED FOR MRI EXAMINATION. THE EXACT CONTEXT OF THE DEATH WAS NOT INDICATED (DURING OR PRIOR THE MRI). IT IS INDICATED THAT THE VENTILATOR DEVICE GAVE A LOW OXYGEN ALARM. THE SETTING OF VENTILATOR WAS MAINLY AT A 100% FIO2 SETTING IN PCV+ MODE. THE DEVICE LOG FILES (SERVICE LOG, ERROR LOG, EVENT LOG) WERE PROVIDED TO HAMILTON MEDICAL AG EXCEPT OF THE TESLASPY LOG FILE AND THE TECHNICAL STATE OF THE DEVICE. THE AVAILABLE LOG FILES SHOW THAT: 'LOW OXYGEN' AND 'OXYGEN SUPPLY FAILED' ALARMS WERE OBSERVED ALONG OTHER PATIENT ALARMS THROUGHOUT THE AVAILABLE EVENT LOGS OF VENTILATION WHEN IT WAS USED THE LAST TIME BEFORE THE DATE OF INCIDENT. DEVICE ALARMED FOR 'LOW OXYGEN' AT 100% FIO2 SETTING DURING VENTILATION IN PCV+ MODE. THE VENTILATION WAS STARTED ON REPORTED DATE OF INCIDENT AT 23:04:37 IN APVCMV MODE AND LATER IT WAS SWITCHED TO PCV+ MODE. THE DEVICE WAS FINALLY SWITCHED TO STANDBY AT 23:11:29 THE SAME DAY (NOTE: STANDBY WAS SET UP BY MEDICAL PERSONAL). THERE IS NEED FOR MEDICAL INTERVENTION REPORTED. THIS INTERVENTION IS NOT FURTHER SPECIFIED NOR EXPLAINED. NEITHER DELAY IN TREATMENT NOR HARM TO USER OR THIRD PARTY HAS BEEN REPORTED. HOWEVER PATIENT HARM IS REPORTED AS THE PATIENT PASSED AWAY DURING THE USE OF THE VENTILATOR. MEASURES TAKEN: THE HOSPITAL TRIED TO REPRODUCE THE SITUATION AFTER THE EVENT. NO TECHNICAL FAILURES WERE FOUND IN THE PROVIDED LOGFILE. THE VENTILATOR DEVICE PASSED THE PRE-OPERATIONAL CHECK SUCCESSFULLY. THE INVESTIGATION IS ONGOING.
THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: - THIS EVENT WITH DATE OF (B)(6) 2024 (EXACT TIME WAS NOT PROVIDED) HAS BEEN ASSESSED AS REPORTABLE. THE PATIENT DIED WHILE BEING VENTILATED WITH A HAMILTON-MR1 VENTILATOR DEVICE. PLEASE NOTE THAT THE HAMILTON-MR1 VENTILATOR IS USED FOR MRI EXAMINATION. THE EXACT CONTEXT OF THE DEATH WAS NOT INDICATED (DURING OR PRIOR THE MRI). IT IS INDICATED THAT THE VENTILATOR DEVICE GAVE A LOW OXYGEN ALARM. THE SETTING OF VENTILATOR WAS MAINLY AT A 100% FIO2 SETTING IN PCV+ MODE. - THE DEVICE LOG FILES (SERVICE LOG, ERROR LOG, EVENT LOG) WERE PROVIDED TO HAMILTON MEDICAL AG EXCEPT OF THE TESLASPY LOG FILE AND THE TECHNICAL STATE OF THE DEVICE. THE AVAILABLE LOG FILES SHOW THAT: 'LOW OXYGEN' AND 'OXYGEN SUPPLY FAILED' ALARMS WERE OBSERVED ALONG OTHER PATIENT ALARMS THROUGHOUT THE AVAILABLE EVENT LOGS OF VENTILATION WHEN IT WAS USED THE LAST TIME BEFORE THE DATE OF INCIDENT. DEVICE ALARMED FOR 'LOW OXYGEN' AT 100% FIO2 SETTING DURING VENTILATION IN PCV+ MODE. THE VENTILATION WAS STARTED ON REPORTED DATE OF INCIDENT AT 23:04:37 IN APVCMV MODE AND LATER IT WAS SWITCHED TO PCV+ MODE. THE DEVICE WAS FINALLY SWITCHED TO STANDBY AT 23:11:29 THE SAME DAY (NOTE: STANDBY WAS SET UP BY MEDICAL PERSONAL). - THERE IS NEED FOR MEDICAL INTERVENTION REPORTED. THIS INTERVENTION IS NOT FURTHER SPECIFIED NOR EXPLAINED. - NEITHER DELAY IN TREATMENT NOR HARM TO USER OR THIRD PARTY HAS BEEN REPORTED. HOWEVER PATIENT HARM IS REPORTED AS THE PATIENT PASSED AWAY DURING THE USE OF THE VENTILATOR. - MEASURES TAKEN: THE HOSPITAL TRIED TO REPRODUCE THE SITUATION AFTER THE EVENT. NO TECHNICAL FAILURES WERE FOUND IN THE PROVIDED LOGFILE. THE VENTILATOR DEVICE PASSED THE PRE-OPERATIONAL CHECK SUCCESSFULLY. THE INVESTIGATION IS ONGOING.
THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: - THIS EVENT WITH DATE OF 29.02.2024 (EXACT TIME WAS NOT PROVIDED) HAS BEEN ASSESSED AS REPORTABLE. THE PATIENT DIED WHILE BEING VENTILATED WITH A HAMILTON-MR1 VENTILATOR DEVICE. PLEASE NOTE THAT THE HAMILTON-MR1 VENTILATOR IS USED FOR MRI EXAMINATION. THE EXACT CONTEXT OF THE DEATH WAS NOT INDICATED (DURING OR PRIOR THE MRI). IT IS INDICATED THAT THE VENTILATOR DEVICE GAVE A LOW OXYGEN ALARM. THE SETTING OF VENTILATOR WAS MAINLY AT A 100% FIO2 SETTING IN PCV+ MODE. - THE DEVICE LOG FILES (SERVICE LOG, ERROR LOG, EVENT LOG) WERE PROVIDED TO HAMILTON MEDICAL AG EXCEPT OF THE TESLASPY LOG FILE AND THE TECHNICAL STATE OF THE DEVICE. THE AVAILABLE LOG FILES SHOW THAT: 'LOW OXYGEN' AND 'OXYGEN SUPPLY FAILED' ALARMS WERE OBSERVED ALONG OTHER PATIENT ALARMS THROUGHOUT THE AVAILABLE EVENT LOGS OF VENTILATION WHEN IT WAS USED THE LAST TIME BEFORE THE DATE OF INCIDENT. DEVICE ALARMED FOR 'LOW OXYGEN' AT 100% FIO2 SETTING DURING VENTILATION IN PCV+ MODE. THE VENTILATION WAS STARTED ON REPORTED DATE OF INCIDENT AT 23:04:37 IN APVCMV MODE AND LATER IT WAS SWITCHED TO PCV+ MODE. THE DEVICE WAS FINALLY SWITCHED TO STANDBY AT 23:11:29 THE SAME DAY (NOTE: STANDBY WAS SET UP BY MEDICAL PERSONAL). - THERE IS NEED FOR MEDICAL INTERVENTION REPORTED. THIS INTERVENTION IS NOT FURTHER SPECIFIED NOR EXPLAINED. - NEITHER DELAY IN TREATMENT NOR HARM TO USER OR THIRD PARTY HAS BEEN REPORTED. HOWEVER PATIENT HARM IS REPORTED AS THE PATIENT PASSED AWAY DURING THE USE OF THE VENTILATOR. - MEASURES TAKEN: THE HOSPITAL TRIED TO REPRODUCE THE SITUATION AFTER THE EVENT. NO TECHNICAL FAILURES WERE FOUND IN THE PROVIDED LOGFILE. THE VENTILATOR DEVICE PASSED THE PRE-OPERATIONAL CHECK SUCCESSFULLY. THE INVESTIGATION IS ONGOING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1320629 | HAMILTON-MR1 | HAMILTON-MR1 | CBK | HAMILTON MEDICAL AG | 161010 | 07630002800761 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Death |