HAMILTON MEDICAL AG
Report
- Report Number
- 3001421318-2023-04050
- Event Type
- Malfunction
- Date Received
- December 1, 2023
- Date of Event
- October 31, 2023
- Report Date
- May 16, 2025
- Manufacturer
- HAMILTON MEDICAL AG
- Product Code
- CBK
- UDI-DI
- 07630002813549
- PMA / PMN Number
- K181216
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ID, US
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
HAMILTON MEDICAL AG CASE NUMBER IS (B)(4). INVESTIGATION ONGOING.
INVESTIGATION ONGOING. HAMILTON MEDICAL AG COMPLAINT NUMBER: CER (B)(4). FOLLOW-UP 1 - CORRECTED INFORMATION: **UDI RELATED DATA QUALITY UPDATES ONLY** FIELD D4 WERE UPDATED WITH FULL UDI INFORMATION AS REQUESTED.
HAMILTON MEDICAL AG CASE NUMBER IS (B)(4). INVESTIGATION ONGOING. ADDITIONAL INFORMATION ADDED IN FOLLOW-UP #2 (B)(4). FIELD B4, G6, H2, H3, H6 AND H11. UPDATED. THE DEVICE ALARMED WITH "LOSS OF EXTERNAL POWER" AND CONTINUED ON BATTERY POWER. THE ISSUE WAS DISCOVERED DURING PRE OPERATIONAL CHECK WITH NO PATIENT INVOLVED. CONSEQUENTLY, THE EVENT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY. THE HAMILTON VENTILATORS UNDERGO MANDATORY PREOPERATIONAL CHECKS BEFORE USAGE. EXTERNAL POWER FUNCTIONALITY, BATTERY STATUS, AND ALARM VERIFICATION ARE PART OF THIS ROUTINE CHECK. A POWER SUPPLY FAILURE IS USUALLY IDENTIFIED DURING THESE CHECKS, ENSURING THE DEVICE IS SAFE FOR USE. IF, DESPITE THE CHECKS, THE ISSUE OCCURS DURING OPERATION AND EXTERNAL POWER IS LOST, THE VENTILATOR IMMEDIATELY ALERTS THE USER WITH THE "EXTERNAL POWER LOSS" ALARM. THIS ALARM ENSURES THAT CLINICAL STAFF ARE AWARE OF THE ISSUE AND CAN TAKE APPROPRIATE ACTION WELL BEFORE IT BECOMES CRITICAL. THE VENTILATOR AUTOMATICALLY SWITCHES TO BATTERY POWER IN THE EVENT OF EXTERNAL POWER FAILURE. THE BATTERY TYPICALLY PROVIDES 1-3 HOURS OF BACKUP OPERATION, ALLOWING AMPLE TIME TO EITHER RESTORE EXTERNAL POWER OR TRANSFER TO ANOTHER VENTILATOR IF NEEDED. IF THE BATTERY LEVEL DROPS FURTHER, ADDITIONAL LOW BATTERY ALARMS PROVIDE FURTHER WARNINGS. THEREFORE, THE POWER LOSS IS NOT A SUDDEN FAILURE LEADING TO IMMEDIATE RISK. THE COMBINATION OF ALARMS, BATTERY BACKUP, AND PRE-USE CHECKS ENSURES THAT THE ISSUE DOES NOT COMPROMISE SAFETY. IN CONCLUSION, THE FAILURE IS DETECTABLE DURING PRE-USE CHECKS WHEN THE DEVICE IS INTENDED TO BE USE AT SOME STAGE WITH A PATIENT (WHICH WAS NOT THE CASE FOR THIS EVENT). THE VENTILATOR HAS BUILT-IN ALARMS AND REDUNDANCY (BATTERY BACKUP) TO MITIGATE RISKS. THERE IS SUFFICIENT TIME TO IMPLEMENT CORRECTIVE ACTIONS BEFORE SAFETY IS COMPROMISED. ALTERNATIVE VENTILATION METHODS ARE AVAILABLE AND EASILY DEPLOYABLE IF NEEDED. THEREFORE, THIS CASE IS NOW (AT THE TIME OF THIS FOLLOW UP REPORT) ASSESSED AS NO LONGER REPORTABLE. THERE IS NO INFORMATION THAT REASONABLY SUGGESTS THAT THE DEVICE HAS MALFUNCTIONED AND THAT THE DEVICE OR A SIMILAR DEVICE WOULD BE LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR.
THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: · THIS EVENT WAS REPORTED TO HAMILTON AS LOSS OF EXTERNAL POWER. · THIS OCCURRENCE WAS NOTICED DURING THE PREOPERATIONAL CHECK. · THE ALARM WAS OBSERVABLE BOTH VISUALLY AND THROUGH HEARING. TE 244001 (EXTERNALPOWERLOSS ). · THE DEVICE LOG FILES WERE PROVIDED TO HAMILTON. · THE ALARM WAS REPRODUCIBLE. · THERE IS NO PATIENT INVOLVEMENT REPORTED. · THERE WAS 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 STILL ONGOING.
THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: · THIS EVENT WAS REPORTED TO HAMILTON AS LOSS OF EXTERNAL POWER. · THIS OCCURRENCE WAS NOTICED DURING THE PREOPERATIONAL CHECK. · THE ALARM WAS OBSERVABLE BOTH VISUALLY AND THROUGH HEARING. TE 244001 (EXTERNALPOWERLOSS ). · THE DEVICE LOG FILES WERE PROVIDED TO HAMILTON. · THE ALARM WAS REPRODUCIBLE. · THERE IS NO PATIENT INVOLVEMENT REPORTED. · THERE WAS 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 STILL ONGOING.
THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: THIS EVENT WAS REPORTED TO HAMILTON AS LOSS OF EXTERNAL POWER. THIS OCCURRENCE WAS NOTICED DURING THE PREOPERATIONAL CHECK. THE ALARM WAS OBSERVABLE BOTH VISUALLY AND THROUGH HEARING. TE 244001 EXTERNALPOWERLOSS ). · THE DEVICE LOG FILES WERE PROVIDED TO HAMILTON. THE ALARM WAS REPRODUCIBLE. THERE IS NO PATIENT INVOLVEMENT REPORTED. THERE WAS 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 STILL ONGOING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1606021 | HAMILTON MEDICAL AG | HAMILTON-T1 | CBK | HAMILTON MEDICAL AG | HAMILTON-T1 | 07630002813549 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |