HAMILTON-G5
Report
- Report Number
- 3001421318-2023-00029
- Event Type
- Malfunction
- Date Received
- January 25, 2023
- Date of Event
- December 14, 2022
- Report Date
- April 2, 2024
- Manufacturer
- HAMILTON MEDICAL AG
- Product Code
- CBK
- UDI-DI
- 07630002800013
- PMA / PMN Number
- K193228
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
NO HARM CAME TO THE PATIENT. VENTILATOR WAS NOT RETURNED TO HMAG. INVESTIGATION HAS BEEN INITIATED AND IS ONGOING. THIS FILE REPORTS THE EVENT STATED IN HAMILTON MEDICAL AG CASE NUMBER (B)(4).
DEVICE DID NOT RETURN TO HAMILTON MEDICAL AG. WE RECEIVED THE LOG FILES OF THE DEVICE AND THE ALARMS WERE REGISTERED IN THE LOG FILES. VENTILATION CONTINUES BUT WITH INCORRECT O2 CONCENTRATION SINCE THE MIXER VALVE WAS DEFECTIVE. TECHNICIAN REPLACED BOTH MIXER VALVES TO SOLVE THE PROBLEM. DEVICE IS BACK IN USE. THIS FILE REPORTS THE EVENT STATED IN HAMILTON MEDICAL AG CASE NUMBER CER (B)(4).
A DETAILED INVESTIGATION WAS PERFORMED BY AN EXPERT FROM THE TECHNICAL SERVICE: SINCE THE COMPLAINT IN QUESTION WAS SUBMITTED TO HAMILTON MEDICAL AG MORE THAN ONE YEAR 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 USED. THE ROOT CAUSE OF THIS COMPLAINT WAS THE AIR INLET MIXER VALVES NOT OPENING PROPERLY. IN CONSEQUENCE (CORRECTION) THE MIXER VALVES WERE REPLACED. NO PATIENT OR USER HARM WAS REPORTED.
HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: "DEVICE SHOWED THE RED ALARM "NO OXYGEN SUPPLY" DURING VENTILATION. DEVICE CHECKED WITH MANUFACTURER SOFTWARE. NO MISTAKE NOTICABLE. THE DEVICE ALSO SHOWS THE RED ALARMS "DISCONNECTION PATIENT SIDE; PEEP LOSS; PRESSURE TOO HIGH; TIDAL VOLUME LOW" IN THE EVENT LOG." NO PATIENT HARM WAS REPORTED.
HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: "DEVICE SHOWED THE RED ALARM "NO OXYGEN SUPPLY" DURING VENTILATION. DEVICE CHECKED WITH MANUFACTURER SOFTWARE. NO MISTAKE NOTICABLE. THE DEVICE ALSO SHOWS THE RED ALARMS "DISCONNECTION PATIENT SIDE; PEEP LOSS; PRESSURE TOO HIGH; TIDAL VOLUME LOW" IN THE EVENT LOG." NO PATIENT HARM WAS REPORTED.
HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: "DEVICE SHOWED THE RED ALARM "NO OXYGEN SUPPLY" DURING VENTILATION. DEVICE CHECKED WITH MANUFACTURER SOFTWARE. NO MISTAKE NOTICABLE. THE DEVICE ALSO SHOWS THE RED ALARMS "DISCONNECTION PATIENT SIDE; PEEP LOSS; PRESSURE TOO HIGH; TIDAL VOLUME LOW" IN THE EVENT LOG." NO PATIENT HARM WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1176797 | HAMILTON-G5 | HAMILTON-G5 VENTILATOR | CBK | HAMILTON MEDICAL AG | HAMILTON-G5 | 07630002800013 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |