HAMILTON MEDICAL AG
Report
- Report Number
- 3001421318-2023-02769
- Event Type
- Malfunction
- Date Received
- July 27, 2023
- Date of Event
- July 14, 2023
- Report Date
- May 27, 2024
- Manufacturer
- HAMILTON MEDICAL AG
- Product Code
- CBK
- UDI-DI
- 07630002808590
- PMA / PMN Number
- K201658
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
HAMILTON MEDICAL AG COMES TO THE CONCLUSION: ROOT CAUSE: FROM THE INFORMATION RECEIVED AND THE ANALYSIS PERFORMED REGARDING THIS CASE, THE MOST PROBABLE ROOT CAUSE IS A SOFTWARE FLAW WHICH HAS BEEN RESOLVED IN SOFTWARE 1.2.1 ONWARDS. THE RELEASE NOTE OF SOFTWARE 1.2.1 READS IN SECTION 7 AS FOLLOWS: "CHANGING A QUICK SETUP NO LONGER OVERWRITES CERTAIN PANELS DURING HIFLOWO2." CONCLUSION: NO FURTHER INVESTIGATION OR CORRECTION WILL BE PERFORMED EXCEPT THOSE MENTIONED ABOVE. THE ALLEGATION IN THIS COMPLAINT WAS CONFIRMED TO BE A COMPLAINT AS A MALFUNCTION OF THE DEVICE COULD BE IDENTIFIED. 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 ON A PATIENT. THE HIFLOWO2 THERAPY CONTINUED AS SET, THE GUI DURING HIFLOWO2 THERAPY IS INDICATING THE ACTUAL FLOW AND THE ACTUALLY MONITORED OXYGEN CONCENTRATION. THE ROOT CAUSE WAS NOT CLEARLY DETERMINED. THE MOST PROBABLE ROOT CAUSE MAY BE RELATED TO A SOFTWARE FLAW REGARDING THE GUI WHICH HAS BEEN RESOLVED IN SOFTWARE 1.2.1 ONWARDS. THE CORRECTION IS TO UPDATE TO THE LATEST SOFTWARE AND PERFORM ALL THE FORESEEN CALIBRATIONS AND TESTS. THERE WAS NO REPORTED PATIENT, USER OR THIRD PARTY HARM.
CORRECTION: NEW CONCLUSION: THE ALLEGATION IN THIS COMPLAINT WAS CONFIRMED TO BE A COMPLAINT. THE VENTILATOR DIDN`T WORK AS INTENDED DUE TO A SOFTWARE ERROR. THE ISSUE IS NOT LIKELY TO BE SERIOUS TO PUBLIC HEALTH BUT HAS POTENTIAL TO CAUSE SERIOUS INJURY OR DEATH, IF IT WERE TO RECUR DURING THE USE WITH A PATIENT. THEREFORE, THE EVENT HAS BEEN DEEMED TO BE A REPORTABLE EVENT. 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 IN USE. NO PATIENT, USER OR THIRD PARTY HARM WAS REPORTED. THE VENTILATOR WAS SENT BACK FOR INVESTIGATION WITH RGA 92412 AND UNDERWENT A BENCHTEST IN A CLIMATE CHAMBER FOR 4 WEEKS AND NONE OF THE ERRORS CONNECTED TO THE ISSUE DESCRIBED BY THE COMPLAINTANT COULD BE DETECTED. NO TECHNICAL ERROR AT ALL COULD BE DETECTED. AT THE TIME OF THE BENCH TEST SW VERSION 1.2.3 WAS ALREADY INSTALLED, HENCE THE SW ERROR RESOLVED. THE ROOT CAUSE MAY WAS DETERMINED TO BE RELATED TO A SOFTWARE ERROR REGARDING THE GUI WHICH HAS BEEN RESOLVED IN SOFTWARE 1.2.1 ONWARDS. THE CORRECTION WAS TO UPDATE TO THE LATEST SOFTWARE 1.2.3 AND PERFORM ALL THE FORESEEN CALIBRATIONS AND TESTS. DUE TO ONGOING FIELD ACTIONS, HAMILTON MEDICAL RECOMMENDS TO INSTALL SW 1.2.3.
CORRECTION IN THIS SECTION H11: "THE RELEASE NOTE OF SOFTWARE 1.2.1 READS IN SECTION 7 AS FOLLOWS: "CHANGING A QUICK SETUP NO LONGER OVERWRITES CERTAIN PANELS DURING HIFLOWO2." REFERS TO SECTION WHICH NOT EXIST IN THIS MDR - COPY AND PASTE ERROR. THE FOLLOWING IS THE CORRECTION CONCLUSION: ROOT CAUSE: FROM THE INFORMATION RECEIVED AND THE ANALYSIS PERFORMED REGARDING THIS CASE, THE MOST PROBABLE ROOT CAUSE IS A SOFTWARE FLAW WHICH HAS BEEN RESOLVED IN SOFTWARE 1.2.1 ONWARDS. CONCLUSION: NO FURTHER INVESTIGATION OR CORRECTION WILL BE PERFORMED EXCEPT THOSE MENTIONED ABOVE. THE ALLEGATION IN THIS COMPLAINT WAS CONFIRMED TO BE A COMPLAINT AS A MALFUNCTION OF THE DEVICE COULD BE IDENTIFIED. 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 ON A PATIENT. THE HIFLOWO2 THERAPY CONTINUED AS SET, THE GUI DURING HIFLOWO2 THERAPY IS INDICATING THE ACTUAL FLOW AND THE ACTUALLY MONITORED OXYGEN CONCENTRATION. THE ROOT CAUSE WAS NOT CLEARLY DETERMINED. THE MOST PROBABLE ROOT CAUSE MAY BE RELATED TO A SOFTWARE FLAW REGARDING THE GUI WHICH HAS BEEN RESOLVED IN SOFTWARE 1.2.1 ONWARDS. THE CORRECTION IS TO UPDATE TO THE LATEST SOFTWARE AND PERFORM ALL THE FORESEEN CALIBRATIONS AND TESTS. THERE WAS NO REPORTED PATIENT, USER OR THIRD PARTY HARM.
HAMILTON MEDICAL AG COMES TO THE CONCLUSION. ROOT CAUSE: INVESTIGAITON ONGOING.
THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: SUMMARY: DEVICE SHOWS STANDBY SCREEN BUT HIGH FLOW O2 THERAPY CONTINUOUS.
THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: SUMMARY: DEVICE SHOWS STANDBY SCREEN BUT HIGH FLOW O2 THERAPY CONTINUOUS.
THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: SUMMARY: DEVICE SHOWS STANDBY SCREEN BUT HIGH FLOW O2 THERAPY CONTINUOUS.
THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: SUMMARY: DEVICE SHOWS STANDBY SCREEN BUT HIGH FLOW O2 THERAPY CONTINUOUS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 637763 | HAMILTON MEDICAL AG | HAMILTON-C6 VENTILATOR | CBK | HAMILTON MEDICAL AG | 07630002808590 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |