Model Number MR850 |
Device Problems
No Audible Alarm (1019); Output Problem (3005)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/03/2022 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The complaint mr850 respiratory humidifier is currently en-route to fisher & paykel healthcare (f&p) for evaluation.We will provide a follow up report upon completion of investigation.
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Event Description
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A distributor in south dakota reported that the audible alarm of a mr850 respiratory humidifier was not functioning.There was no patient involvement.
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Event Description
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A distributor in south dakota reported that the audible alarm of a mr850 respiratory humidifier was not functioning.There was no patient involvement.
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Manufacturer Narrative
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Ps396902 method: the pcb of the complaint (b)(4) respiratory humidifier was returned to fisher & paykel healthcare in new zealand for investigation, where it was performance tested and electrically evaluated.Results: performance testing revealed that the pcb did not cause any errors or alarms.Electrical resistance testing revealed the speaker was functioning as intended and the impedence measured was within an acceptable range.Conclusion: we are unable to determine the cause of the reported event as no fault was found with the returned pcb.Our mr850 product technical manual contains a maintenance schedule which instructs the user to conduct annual visual checking and performance testing of the (b)(4) 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 (b)(4) is equipped with visual alarm indicators in addition to the audible alarm.
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Search Alerts/Recalls
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