HAMILTON-T1
Report
- Report Number
- 3001421318-2023-04096
- Event Type
- Malfunction
- Date Received
- December 7, 2023
- Date of Event
- November 23, 2023
- Report Date
- February 10, 2025
- Manufacturer
- HAMILTON MEDICAL AG
- Product Code
- CBK
- UDI-DI
- 07630002806091
- PMA / PMN Number
- K181216
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
HAMILTON MEDICAL AG CASE NUMBER IS (B)(4). INVESTIGATION ONGOING. 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, D3, D4, G6, H2, H4, H11.
HAMILTON MEDICAL AG CASE NUMBER IS CER (B)(4) . INVESTIGATION ONGOING.
HAMILTON MEDICAL AG CASE NUMBER IS (B)(4). INVESTIGATION ONGOING. HAMILTON MEDICAL AG COMPLAINT NUMBER: (B)(4). FOLLOW-UP 1 - CORRECTED INFORMATION: FIELD D4 WAS UPDATED WITH FULL UDI INFORMATION. UPDATED FIELDS: B4, D1, D3, D4, G6, H2, H4, H11. HAMILTON MEDICAL AG COMPLAINT NUMBER: (B)(4). FOLLOW-UP 2 - DEVICE EVALUATION: ROOT CAUSE: HAMILTON MEDICAL AG RECEIVED THE LOGFILES OF THE DEVICE FOR ANALYSIS. ALL IMPORTANT ACTIONS SUCH AS OPERATOR SETTINGS, ACTIONS AND ALARMS, ETC. ARE DOCUMENTED IN THE LOGFILES. HAMILTON MEDICAL AG DID NOT RECEIVE THE VENTILATOR ITSELF FOR INVESTIGATION. A MALFUNCTION OF THE DEVICE COULD NOT BE IDENTIFIED. WITH THIS INVESTIGATION IT HAS NOT BEEN CONFIRMED THAT THE DEVICE FAILED TO MEET ITS SPECIFICATIONS AT THE TIME OF THE EVENT WHEN THE VENTILATOR WAS USED. THE ROOT CAUSE FOR THE SPORADIC OCCURRENCE OF FALSE-POSITIVE TE 232003 MESSAGES DURING HIGHFLOWO2 THERAPY, WAS A VERY PARTICULAR SET-UP OF THE DEVICE AND BREATHING CIRCUIT BY THE USER. THE USER REPORTEDLY WANTED TO EASE AND ENABLE A RAPID SWITCH TO NIV MODE. THIS SET-UP WAS NOT CONFORM (USE ERROR), THOUGH, WITH THE RECOMMENDATIONS OF THE OPERATOR'S MANUAL FOR THE USE OF DUAL LIMB BREATHING SETS IN CONNECTION WITH HIFLOW THERAPY AND NIV MODE. THE FOLLOWING CORRECTION WAS PERFORMED: THE VENTILATOR WAS CHECKED BY THE SERVICE TECHNICIAN ON SITE. ALL PRESSURE SENSORS WERE WORKING PERFECTLY. THE PAW SENSOR WORKED CORRECT AND ACCURATE. THE SETUP WAS PHOTOGRAPHED AND THE SERVICE TECHNICIAN DISCUSSED THE ISSUE WITH THE CUSTOMER. THE REPORTED EVENT IS NO LONGER CONSIDERED REPORTABLE: THE VENTILATOR DID NOT MALFUNCTION AND DID NOT CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY. UPDATED FIELDS: B4, G1, G6, H2, H6, H7, H11.
THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: · THIS EVENT WAS REPORTED TO HAMILTON AS VENTILATOR DEVICE SPORADICALLY ALARMS WHEN HIGHFLOWO2 MODE IS USED. · THIS OCCURRENCE WAS NOTICED DURING PATIENT VENTILATION. · THE ALARM WAS OBSERVABLE BOTH VISUALLY AND THROUGH HEARING. TE 232003 (PAWSENSORDEFECT). · THE DEVICE LOG FILES WERE PROVIDED TO HAMILTON. · THERE IS PATIENT INVOLVEMENT REPORTED. THIS EVENT OCCURRED DURING VENTILATION. · THERE IS NO NEED FOR ANY MEDICAL INTERVENTION REPORTED. · NEITHER DELAY IN TREATMENT NOR HARM TO THE PATIENT, USER OR THIRD PARTY HAS BEEN REPORTED. THE INVESTIGATION IS STILL ONGOING.
THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: THIS EVENT WAS REPORTED TO HAMILTON AS VENTILATOR DEVICE SPORADICALLY ALARMS WHEN HIGHFLOWO2 MODE IS USED. THIS OCCURRENCE WAS NOTICED DURING PATIENT VENTILATION. THE ALARM WAS OBSERVABLE BOTH VISUALLY AND THROUGH HEARING. TE 232003 (PAWSENSORDEFECT). THE DEVICE LOG FILES WERE PROVIDED TO HAMILTON. THERE IS PATIENT INVOLVEMENT REPORTED. THIS EVENT OCCURRED DURING VENTILATION. THERE IS NO NEED FOR ANY MEDICAL INTERVENTION REPORTED. NEITHER DELAY IN TREATMENT NOR HARM TO THE PATIENT, USER OR THIRD PARTY HAS BEEN REPORTED. THE INVESTIGATION IS STILL ONGOING.
THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: THIS EVENT WAS REPORTED TO HAMILTON AS VENTILATOR DEVICE SPORADICALLY ALARMS WHEN HIGHFLOWO2 MODE IS USED. THIS OCCURRENCE WAS NOTICED DURING PATIENT VENTILATION. THE ALARM WAS OBSERVABLE BOTH VISUALLY AND THROUGH HEARING. TE 232003 (PAWSENSORDEFECT). THE DEVICE LOG FILES WERE PROVIDED TO HAMILTON. THERE IS PATIENT INVOLVEMENT REPORTED. THIS EVENT OCCURRED DURING VENTILATION. THERE IS NO NEED FOR ANY MEDICAL INTERVENTION REPORTED. NEITHER DELAY IN TREATMENT NOR HARM TO THE PATIENT, USER OR THIRD PARTY HAS BEEN REPORTED. THE INVESTIGATION IS STILL ONGOING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 222095 | HAMILTON-T1 | HAMILTON-T1 | CBK | HAMILTON MEDICAL AG | 161009 | 07630002806091 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |