Model Number MR850 |
Device Problem
Device Alarm System (1012)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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(b)(4) we are currently in the process of completing 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 healthcare facility in saint louis reported that the audible alarms of a mr850 respiratory humidifier were not functioning.There was no reported patient involvement.
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Manufacturer Narrative
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(b)(4).Method: the subject mr850 respiratory humidifier was returned to the fisher & paykel (f&p) healthcare service centre in the usa where it was inspected by a trained f&p healthcare service technician.The unit was performance tested and the speaker was confirmed to be faulty.The pcb was replaced and the subject pcb was received by f&p healthcare new zealand for additional evaluation.Results: performance testing of the subject pcb confirmed that the audible alarm was not functioning.There was no visible damage to the speaker and testing confirmed that the speaker impedance was out of specification.Conclusion: our investigation was unable to determine the cause of the reported speaker fault.The 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 healthcare facility in saint louis reported that the audible alarm of a mr850 respiratory humidifier was not functioning.There was no reported patient involvement.
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Search Alerts/Recalls
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