HAMILTON MEDICAL AG
Report
- Report Number
- 3001421318-2023-03679
- Event Type
- Malfunction
- Date Received
- October 30, 2023
- Date of Event
- October 17, 2023
- Report Date
- November 26, 2024
- Manufacturer
- HAMILTON MEDICAL AG
- Product Code
- CBK
- PMA / PMN Number
- K193228
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- 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 FUNCTION, AND HAVE THE SAME DEVICE CLASSIFICATION AND PRODUCT CODE UNDER 21 CFR 868.5895. DISPLAY DISTURBED. VENTILATION CONTINOUS. IP ESM WAS REPLACED.
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. 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 WHILE THE VENTILATOR WAS USED. THE ROOT CAUSE WAS DETERMINED TO BE A DEFECTIVE IP ESM BOARD IN CONSEQUENCE (CORRECTION) THE IP ESM BOARD WAS REPLACED. THERE WAS NO PATIENT OR USER HARM. IN FUTURE HAMILTON MEDICAL AG WILL REPORT AN EVENT SIMILAR TO THIS ISSUE AS IT WILL BE DEEMED A REPORTABLE EVENT.
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. 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 WHILE THE VENTILATOR WAS USED. THE ROOT CAUSE WAS DETERMINED TO BE A DEFECTIVE IP ESM BOARD IN CONSEQUENCE (CORRECTION) THE IP ESM BOARD WAS REPLACED. THERE WAS NO PATIENT OR USER HARM. IN FUTURE HAMILTON MEDICAL AG WILL REPORT AN EVENT SIMILAR TO THIS ISSUE AS IT WILL BE DEEMED A REPORTABLE EVENT. HAMILTON MEDICAL AG COMPLAINT NUMBER: (B)(4). FOLLOW-UP 2 - CORRECTED INFORMATION: **UDI RELATED DATA QUALITY UPDATES ONLY** 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.
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Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 130488 | HAMILTON MEDICAL AG | HAMILTON-S1 VENTILATOR | CBK | HAMILTON MEDICAL AG | HAMILTON-S1 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |