Model Number MR850 |
Device Problems
No Audible Alarm (1019); Therapeutic or Diagnostic Output Failure (3023)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/26/2022 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).We are currently in the process of finalising our investigation.We will provide a follow up report upon completion of our investigation.
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Event Description
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A distributor in texas reported that the speaker of a mr850 respiratory humidifier was not functioning properly.There was no reported patient involvement.
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Manufacturer Narrative
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(b)(4).Method: the complaint mr850 respiratory humidifier was returned to our fisher & paykel heathcare (f&p) service centre in california, where is was inspected by a trained f&p service technician.Result: we were not able to confirm if the audible alarm of the complaint mr850 respiratory humidifier was functioning.Conclusion: we are unable to determine the cause of the reported event.Our mr850 product technical manual contains a maintenance schedule which instructs the user to conduct annual visual checking and performance testing of the mr850 heater base.In addition, the product technical manual also states that "all servicing procedures should be followed by a humidifier test, and an electrical safety test to ensure proper operation".The mr850 is equipped with visual alarm indicators in addition to the audible alarm.
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Event Description
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A distributor in texas reported that the speaker of a mr850 respiratory humidifier was not functioning properly.There was no reported patient involvement.
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Search Alerts/Recalls
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