HAMILTON-S1
Report
- Report Number
- 3001421318-2024-01046
- Event Type
- Malfunction
- Date Received
- April 29, 2024
- Date of Event
- April 12, 2024
- Report Date
- November 26, 2024
- Manufacturer
- HAMILTON MEDICAL AG
- Product Code
- CBK
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- 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.
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. A DETAILED INVESTIGATION WAS PERFORMED BY AN EXPERT FROM THE TECHNICAL SERVICE: 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. THE ROOT CAUSE WAS DETERMINED TO BE AUTOZERO VALVES ON THE SENSOR BOARD NOT WORKING PROPERLY. IN CONSEQUENCE THE SENSOR BOARD 2 WAS REPLACED (P/N (B)(6)). THE UNIT PASSED ALL TESTS AND WAS THEN OPERATIONAL. THERE WAS NO PATIENT OR USER HARM. THIS DEVICE WAS PRODUCED BEFORE 2015. NO UDI AVAILABLE.
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. A DETAILED INVESTIGATION WAS PERFORMED BY AN EXPERT FROM THE TECHNICAL SERVICE: 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. THE ROOT CAUSE WAS DETERMINED TO BE AUTOZERO VALVES ON THE SENSOR BOARD NOT WORKING PROPERLY. IN CONSEQUENCE THE SENSOR BOARD 2 WAS REPLACED (P/N 155699). THE UNIT PASSED ALL TESTS AND WAS THEN OPERATIONAL. THERE WAS NO PATIENT OR USER HARM. THIS DEVICE WAS PRODUCED BEFORE 2015. NO UDI AVAILABLE. HAMILTON MEDICAL AG COMPLAINT NUMBER: CER (B)(4) FOLLOW-UP 2 - CORRECTED INFORMATION: WITHIN THE UDI-PI PROJECT, HAMILTON MEDICAL REALIZED THAT THE REPORTED DEVICE (BRAND NAME: HAMILTON-S1; VERSION / MODEL / 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.
HAMILTON MEDICAL AG RECEIVED THE FOLLOWING INCIDENT DESCRIPTION: THE DEVICE ALARMED WITH TF 5510, 5511 DURING STANDBY.
HAMILTON MEDICAL AG RECEIVED THE FOLLOWING INCIDENT DESCRIPTION: THE DEVICE ALARMED WITH TF 5510, 5511 DURING STANDBY.
HAMILTON MEDICAL AG RECEIVED THE FOLLOWING INCIDENT DESCRIPTION: THE DEVICE ALARMED WITH TF 5510, 5511 DURING STANDBY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 999864 | HAMILTON-S1 | HAMILTON-S1 VENTILATOR | CBK | HAMILTON MEDICAL AG | 159005 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |