HAMILTON-T1
Report
- Report Number
- 3001421318-2023-23266
- Event Type
- Death
- Date Received
- November 16, 2023
- Date of Event
- April 6, 2021
- Report Date
- July 31, 2024
- Manufacturer
- HAMILTON MEDICAL AG
- Product Code
- CBK
- PMA / PMN Number
- K181216
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
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 WAS NOT CONFIRMED THAT THE DEVICE FAILED TO MEET ITS SPECIFICATIONS AT THE TIME OF THE EVENT WHILE THE VENTILATOR WAS USED WITH A PATIENT. THE DEATH OF THE PATIENT WAS NOT CONFIRMED BUT A POTENTIAL DETERIORATION IN THE STATE OF HEALTH OF THE PATIENT WAS INDICATED. THE FINAL PATIENT'S STATE OF HEALTH IS UNKNOWN. THE ROOT CAUSE WAS DETERMINED TO BE A USER ERROR. NO CORRECTION WAS CONDUCTED ON THE AFFECTED VENTILATOR. DUE TO POTENTIAL PATIENT HARM, THIS COMPLAINT IS DEEMED REPORTABLE.
THE COMPLAINT HAS BEEN REOPENED AND REVIEWED ACCORDING TO FDA FORM 483 INSPECTIONAL OBSERVATION EMS NO, 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 WAS NOT CONFIRMED THAT THE DEVICE FAILED TO MEET ITS SPECIFICATIONS AT THE TIME OF THE EVENT WHILE THE VENTILATOR WAS USED WITH A PATIENT. THE DEATH OF THE PATIENT WAS NOT CONFIRMED BUT A POTENTIAL DETERIORATION IN THE STATE OF HEALTH OF THE PATIENT WAS INDICATED. THE FINAL PATIENT'S STATE OF HEALTH IS UNKNOWN. THE ROOT CAUSE WAS DETERMINED TO BE A USER ERROR. NO CORRECTION WAS CONDUCTED ON THE AFFECTED VENTILATOR. DUE TO POTENTIAL PATIENT HARM, THIS COMPLAINT IS DEEMED REPORTABLE. 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.
"HAMILTON VENTILATORY UM 519418- IN USE WITH PATIENT IN OSH ICU- SUDDEN FLOW SENSOR FAILURE, ALARM, STARTED READING TIDAL VOLUMES >5000 AND MINUTE VENTILATION >45 SO MACHINE STOPPED DELIVERING VOLUME. PATIENT DECOMPENSATED SATS TO 50%, HAD TO DISCONNECT AND AMBUBAG VENTILATE. ABLE TO TRANSITION BACK TO ICU VENT, TRIED RECRUITMENT AND VENT CHANGES- DID NOT RECOVER. HAMILTON VENT SHUT DOWN- ALL TUBING AND FLOW SENSOR SWITCHED OUT AND RE CALIBRATED- TRANSITIONED PT BACK TO HAMILTON VENT AND COMPLETED TRANSPORT BUT PATIENT ONLY RECOVERED TO 77% SATS WAS 91% AT TIME OF INCIDENT." LOG REVIEW REQUEST. DEVICE TYPE AND SERIAL NUMBER: (B)(6). DATE OF OCCURANCE: (B)(6) 2021. TIME OF OCCURANCE (I.E. MORNING, BETWEEN 8-11AM): BETWEEN 13:13 TO 13:16. ISSUE WITH VENT (E.G. SHUTS DOWN, WON'T CALIBRATE, ETC): UNIT HAD A HIGH VT THAN SHUT DOWN. WAS THE VENT ON A PATIENT? YES, THE PATIENT EXPIRED. WAS THIS EVENT REPORTED TO THE FDA? UNKNOWN. WAS THERE PATIENT HARM? PATIENT EXPIRED. WAS THIS UNIT BOUGHT FROM A THIRD PARTY VENDOR (NOT DIRECTLY FROM HAMILTON)? YES, UNIT WAS BOUGHT FROM HAMILTON. WHEN WAS THE LAST PM/SERVICE OF THIS DEVICE( MAY2019)? THE IN-HOUSE BIOMED COMPLETED THE P.M ON (B)(6) 2020. CAN BIOMED REPLICATE PROBLEM? BIOMED COMPETED THE FLOW SENSOR CALIBRATION AND RAN THE UNIT FOR 4 HOURS WITH NO ISSUES STEPS BIOMED TOOK TO FIND/FIX PROBLEMS? (I.E. CHECKED FLOWS, REPLACED PARTS, ETC) NO. BIOMED IS SENDING IN THE UNIT UNDER RGA 18235M.N.
THE NOTE LEFT BY THE OPERATOR. "HAMILTON VENTILATORY UM 519418- IN USE WITH PATIENT IN OSH ICU- SUDDEN FLOW SENSOR FAILURE, ALARM, STARTED READING TIDAL VOLUMES >5000 AND MINUTE VENTILATION >45 SO MACHINE STOPPED DELIVERING VOLUME. PATIENT DECOMPENSATED SATS TO 50%, HAD TO DISCONNECT AND AMBUBAG VENTILATE. ABLE TO TRANSITION BACK TO ICU VENT, TRIED RECRUITMENT AND VENT CHANGES- DID NOT RECOVER. HAMILTON VENT SHUT DOWN- ALL TUBING AND FLOW SENSOR SWITCHED OUT AND RE CALIBRATED- TRANSITIONED PT BACK TO HAMILTON VENT AND COMPLETED TRANSPORT BUT PATIENT ONLY RECOVERED TO 77% SATS WAS 91% AT TIME OF INCIDENT." LOG REVIEW REQUEST. DEVICE TYPE AND SERIAL NUMBER: T1 S.N (B)(6). DATE OF OCCURENCE: 4-6-2021. TIME OF OCCURANCE (I.E. MORNING, BETWEEN 8-11AM): BETWEEN 13:13 TO 13:16. ISSUE WITH VENT (E.G. SHUTS DOWN, WON'T CALIBRATE, ETC): UNIT HAD A HIGH VT THAN SHUT DOWN. WAS THE VENT ON A PATIENT? YES, THE PATIENT EXPIRED. WAS THIS EVENT REPORTED TO THE FDA? UNKNOWN. WAS THERE PATIENT HARM? PATIENT EXPIRED. WAS THIS UNIT BOUGHT FROM A THIRD PARTY VENDOR (NOT DIRECTLY FROM HAMILTON)? YES, UNIT WAS BOUGHT FROM HAMILTON. WHEN WAS THE LAST PM/SERVICE OF THIS DEVICE (MAY 2019)? THE IN-HOUSE BIOMED COMPLETED THE P.M ON JULY 2020. CAN BIOMED REPLICATE PROBLEM? BIOMED COMPETED THE FLOW SENSOR CALIBRATION AND RAN THE UNIT FOR 4 HOURS WITH NO ISSUES. STEPS BIOMED TOOK TO FIND/FIX PROBLEMS? (I.E. CHECKED FLOWS, REPLACED PARTS, ETC): NO. BIOMED IS SENDING IN THE UNIT UNDER RGA 18235M.N.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2126355 | HAMILTON-T1 | HAMILTON-T1 | CBK | HAMILTON MEDICAL AG | 161006 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other| D| R |