Model Number MK06000 |
Device Problems
Gas Output Problem (1266); Decrease in Pressure (1490); Reset Problem (3019)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/16/2021 |
Event Type
malfunction
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Event Description
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During an emergency trauma or case in the middle of the night, the screen on the perseus froze and the anesthetist was unable to make any ventilator changes on the machine.No injury reported.
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Manufacturer Narrative
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The investigation was started, the result will be provided in a follow-up report.
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Manufacturer Narrative
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The provided information was analysed for the investigation.The description of the event and the fact, that the compact flash card was exchanged on side leads to the conclusion, that the reported symptom was most likely due to a faulty compact flash card causing a reboot of the device in question.In case of a reset of the processors of the therapy control unit m16 therapy is discontinued for a maximum of 15 seconds, before therapy will be resumed with the latest valid settings.During reboot the touchscreen is inoperable.The device was tested on site according to manufacturer's specification and returned into use.The number of similar cases, related to the same root cause, is within the expected range of the respective risk assessment and thus accepted.
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Event Description
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During an emergency trauma or case in the middle of the night, the screen on the perseus froze and the anesthetist was unable to make any ventilator changes on the machine.No injury reported.
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Manufacturer Narrative
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Due to a technical issue with our internal emdr system we submitted for the form fda 3500a an incorrect value for the field h3.Not returned to manufacturer.
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Event Description
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During an emergency trauma or case in the middle of the night, the screen on the perseus froze and the anesthetist was unable to make any ventilator changes on the machine.No injury reported.
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Search Alerts/Recalls
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