HAMILTON-MR1
Report
- Report Number
- 3001421318-2024-01804
- Event Type
- Malfunction
- Date Received
- July 30, 2024
- Date of Event
- July 1, 2024
- Report Date
- July 23, 2025
- Manufacturer
- HAMILTON MEDICAL AG
- Product Code
- CBK
- UDI-DI
- 07630002800761
- PMA / PMN Number
- K153046
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, 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 - CORRECTED INFORMATION: UDI RELATED DATA QUALITY UPDATES ONLY FIELD D4 WAS UPDATED WITH FULL UDI INFORMATION.
HAMILTON MEDICAL AG CASE NUMBER IS (B)(4). 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, D4, G6, H2, H4, H11. FOLLOW-UP 2 - ADDITIONAL INFORMATION: THE ENTRY FIELDS B4, G6, H2, H3, H6 AND H11 HAVE BEEN UPDATED. IT WAS REPORTED THAT THE DEVICE GENERATED A "FAN FAILURE" ALARM. NO PATIENT INVOLVEMENT. CONSEQUENTLY, THE EVENT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY TO A PATIENT. THE CUSTOMER DID NOT PROVIDE EVENT LOGS FOR ANALYSIS. A REPLACEMENT FAN WAS SHIPPED TO THE CUSTOMER. NO CONFIRMATION WAS RECEIVED REGARDING THE RESOLUTION OF THE ISSUE. ALTHOUGH THE OUTCOME COULD NOT BE VERIFIED, IT IS ASSUMED THAT THE ISSUE WAS RESOLVED BY REPLACING THE FAN, AS NO FURTHER COMPLAINTS HAVE BEEN REPORTED.
THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: - HAMILTON MEDICAL AG RECEIVED THE FOLLOWING INCIDENT DESCRIPTION: "FAN FAILURE". - WHEN THIS WAS NOTICED, THE VENTILATOR WAS NOT IN USE TO VENTILATE A PATIENT. NO FURTHER DETAILS ABOUT WHEN THIS HAPPENED WERE REPORTED TO HAMILTON MEDICAL AG. - THERE IS NO PATIENT INVOLVEMENT REPORTED. - 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 ONGOING.
THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: HAMILTON MEDICAL AG RECEIVED THE FOLLOWING INCIDENT DESCRIPTION: "FAN FAILURE". WHEN THIS WAS NOTICED, THE VENTILATOR WAS NOT IN USE TO VENTILATE A PATIENT. NO FURTHER DETAILS ABOUT WHEN THIS HAPPENED WERE REPORTED TO HAMILTON MEDICAL AG. THERE IS NO PATIENT INVOLVEMENT REPORTED. 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 ONGOING.
THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: - HAMILTON MEDICAL AG RECEIVED THE FOLLOWING INCIDENT DESCRIPTION: "FAN FAILURE". - WHEN THIS WAS NOTICED, THE VENTILATOR WAS NOT IN USE TO VENTILATE A PATIENT. NO FURTHER DETAILS ABOUT WHEN THIS HAPPENED WERE REPORTED TO HAMILTON MEDICAL AG. - THERE IS NO PATIENT INVOLVEMENT REPORTED. - 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 ONGOING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 187245 | HAMILTON-MR1 | HAMILTON-MR1 | CBK | HAMILTON MEDICAL AG | 161010 | NOT APPLICABLE | 07630002800761 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |