HAMILTON MEDICAL AG
Report
- Report Number
- 3001421318-2022-00011
- Event Type
- Malfunction
- Date Received
- September 15, 2022
- Date of Event
- September 7, 2022
- Report Date
- November 25, 2022
- Manufacturer
- HAMILTON MEDICAL AG
- Product Code
- CBK
- UDI-DI
- 07630002813549
- PMA / PMN Number
- K181216
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
BASED ON THE RECEIVED INFORMATION, WE CANNOT ESTABLISH THE ROOT CAUSE OF THE EVENT. NO FURTHER INFORMATION WAS RECEIVED ABOUT THE CASE TO THIS DATE. WHEN FURTHER INFORMATION WILL BE RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED. HAMILTON MEDICAL AG CASE NUMBER IS: (B)(4).
FIRST INSIGHTS: DEVICE WAS STARTED ON (B)(6) 2022 AT 23:31:17 WITH HI FLOW MODE AT 23:53:37 THE FIRST CHECK PATIENT INTERFACE IS DEPOSITED FURTHER CHECK PATIENT INTERFACES FOLLOW UNTIL TE 232005 OCCURS AT 00:05:15. FURTHER CHECK PATIENT INTERFACES ARE STORED AND THE ALARM SILENCE BUTTON IS ACTIVATED SEVERAL TIMES AND OXYGEN VALUES [?][?]ARE ADJUSTED BY THE USER ON (B)(6) 2022 AT 00:55:44 THE DEVICE IS PUT INTO STANDBY CONCLUSION: THE TE 232005 WAS TRIGGERED BECAUSE THE BLOWER OPERATING TEMPERATURE WAS OVER >92 DEGREES DURING HI FLOW THERAPY. THE BLOWER IS A 1ST GENERATION BLOWER WHICH *DOES NOT HAVE A HEAT SINK". THE BLOWER IS THE ORIGINAL BLOWER THAT WAS INSTALLED IN PRODUCTION AT THE TIME THE TE 232005 WAS CANCELED AFTER THE BLOWERTEMP. HAS COOLED DOWN, THE ALARM WAS NO LONGER TRIGGERED AFTER THIS EVENT CHECK PATIENT INTERFACE ALARMS HAVE INCREASED CAUSE: DUE TO THE FREQUENT CHECK PATIENT INTERFACE ALARMS, THE BLOWER WAS MORE HEAVILY LOADED AND HAD TO REACH THE SET FLOW MORE OFTEN DUE TO THE INCREASED LOAD, THE BLOWER TEMPERATURE INCREASED UNTIL THE SAFETY ALARM TE 232005 WAS TRIGGERED. SINCE THE BLOWER DOES NOT HAVE AN EXTERNAL HEAT SINK, THE TEMPERATURE LIMIT FOR THE TE232005'S TRIGGER WAS EXCEEDED MORE QUICKLY AND EASILY. THE CHECK PATIENT INTERFACE ALARMS ARE PROBABLY CAUSED BY THE PATIENT OR BY A BLOCKAGE IN THE INSPIRATORY TUBE. COUNTER-PRESSURE FROM THE PATIENT CANNOT BE RULED OUT EITHER. REST OF THE PROCEDURE: THE USER SHOULD REACT AS SOON AS THE CHECK PATIENT INTERFACE ALARMS APPEAR AND, IF NECESSARY, ADJUST THE SETTINGS, ALSO CHECK THE INSPIRATORY HOSE. BACK PRESSURE FROM THE PATIENT SHOULD BE AVOIDED. THE BLOWER CAN CONTINUE TO BE USED BECAUSE NO MORE TECHNICAL PROBLEMS HAVE OCCURRED, THE BLOWER IS NOT DEFECTIVE BECAUSE NO ERROR MESSAGE APPEARS THE NEXT TIME IT IS STARTED. THE INCREASED TEMPERATURE OF THE BLOWER CAN AFFECT THE SERVICE LIFE!!! HAMILTON MEDICAL AG CASE NUMBER IS: (B)(4). FOLLOW-UP 1: A FOLLOW- UP REPORT IS SUBMITTED AS ON THE 21TH NOVEMBER 2022 WE HAVE RECEIVED THE FOLLOWING ADDITIONAL INFORMATION: ACCORDING TO THE BIOMED OF THE FACILITY, THE RT IN QUESTION MAY NOT BE FAMILIAR WITH THE PRODUCT. THE ''POP'' THEY ALLEGEDLY HEARD WAS FROM THE FRONT PANEL BOARD OF THE DEVICE, THE GLUE FROM THE FPB IS VERY LOUD WHEN USED IN CERTAIN AREAS. AS FOR THE SHOCK AND THE SMELL A FULL INSPECTION WAS DONE ON ALL BOARD LEVEL COMPONENTS WITH NO EVIDENCE OF ANY COMPONENT BEING DAMAGED.
THE FOLLOWING WAS REPORTED: RT CLAIMS SHE WAS ELECTROCUTED/SHOCKED WHEN TURNING ON MACHINE BEFORE PATIENT USE. THEY HEARD A LOUD POPPING AND SMELL COMING FROM THE MACHINE. NO FURTHER INFORMATION HAS BEEN REVEIVED SO FAR.
THE FOLLOWING WAS REPORTED: RT CLAIMS SHE WAS ELECTROCUTED/SHOCKED WHEN TURNING ON MACHINE BEFORE PATIENT USE. THEY HEARD A LOUD POPPING AND SMELL COMING FROM THE MACHINE. NO FURTHER INFORMATION HAS BEEN RECEIVED SO FAR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 124077 | HAMILTON MEDICAL AG | HAMILTON-T1 | CBK | HAMILTON MEDICAL AG | HAMILTON-T1 | 07630002813549 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Other |