HAMILTON-S1
Report
- Report Number
- 3001421318-2023-04290
- Event Type
- Malfunction
- Date Received
- December 20, 2023
- Date of Event
- December 11, 2023
- Report Date
- September 6, 2024
- Manufacturer
- HAMILTON MEDICAL AG
- Product Code
- CBK
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- 505
Narratives
THE HAMILTON-S1 IS NOT DISTRIBUTED IN THE UNITED STATES; HOWEVER, HAMILTON MEDICAL AG CONSIDERS THE HAMILTON-S1 SIMILAR TO THE HAMILTON-G5 (K193228) IN THAT THE TWO VENTILATORS HAVE BASIC DESIGN AND PERFORMANCE CHARACTERISTICS RELATED TO DEVICE SAFETY AND EFFECTIVENESS, HAVE THE SAME INTENDED USE AND FUCTION, AND HAVE THE SAME DEVICE CLASSIFICATION AND PRODUCT CODE UNDER 21 CFR 868.5895. INVESTIGATION IS ONGOING. WITHIN THE UDI-PI PROJECT, HAMILTON MEDICAL DID REALIZE THAT THE REPORTED DEVICE (BRAND NAME: HAMILTON-S1 / MODEL NUMBER: 159005 / CATALOG NUMBER: 159005) IN THE PRESENT MDR IS NOT FULFILLING THE CRITERIA OF SIMILARITY FOR A DEVICE MARKETED IN THE U.S., THEREFORE THIS EVENT IS NO LONGER CONSIDERED REPORTABLE TO FDA AND NO UDI-PI IS GOING TO BE PROVIDED.
THE HAMILTON-S1 IS NOT DISTRIBUTED IN THE UNITED STATES; HOWEVER, HAMILTON MEDICAL AG CONSIDERS THE HAMILTON-S1 SIMILAR TO THE HAMILTON-G5 (K193228) IN THAT THE TWO VENTILATORS HAVE BASIC DESIGN AND PERFORMANCE CHARACTERISTICS RELATED TO DEVICE SAFETY AND EFFECTIVENESS, HAVE THE SAME INTENDED USE AND FUCTION, AND HAVE THE SAME DEVICE CLASSIFICATION AND PRODUCT CODE UNDER 21 CFR 868.5895. INVESTIGATION IS ONGOING. HAMILTON MEDICAL AG COMPLAINT NUMBER: (B)(4). FOLLOW-UP 1 - CORRECTED INFORMATION: UDI RELATED DATA QUALITY UPDATES ONLY. FIELD D4 WAS NOT UPDATED WITH FULL UDI INFORMATION AS REQUESTED SINCE THE DEVICE WAS MANUFACTURED BEFORE 2015.
THE HAMILTON-S1 IS NOT DISTRIBUTED IN THE UNITED STATES; HOWEVER, HAMILTON MEDICAL AG CONSIDERS THE HAMILTON-S1 SIMILAR TO THE HAMILTON-G5 (K193228) IN THAT THE TWO VENTILATORS HAVE BASIC DESIGN AND PERFORMANCE CHARACTERISTICS RELATED TO DEVICE SAFETY AND EFFECTIVENESS, HAVE THE SAME INTENDED USE AND FUCTION, AND HAVE THE SAME DEVICE CLASSIFICATION AND PRODUCT CODE UNDER 21 CFR 868.5895. INVESTIGATION IS ONGOING.
HAMILTON MEDICAL AG RECEIVED THE FOLLOWING INCIDENT DESCRIPTION: THE UNIT ALERTED ON TF8912.
HAMILTON MEDICAL AG RECEIVED THE FOLLOWING INCIDENT DESCRIPTION: THE UNIT ALERTED ON TF8912.
HAMILTON MEDICAL AG RECEIVED THE FOLLOWING INCIDENT DESCRIPTION: THE UNIT ALERTED ON TF8912.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2110486 | HAMILTON-S1 | HAMILTON-S1 | CBK | HAMILTON MEDICAL AG | 159005 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |