Model Number IW990 |
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 Type
malfunction
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Manufacturer Narrative
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(b)(4).The complaint iw990 wall mount infant warmer is currently en route to fisher & paykel healthcare (f&p) new zealand for evaluation.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 the (b)(6) reported that the iw990 wall mount infant warmer speaker was not working.There was no reported patient consequence.
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Event Description
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A healthcare facility in the uk reported that the audio alarm of a iw900 pcb assay control manual was not working.There was no reported patient consequence.
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Manufacturer Narrative
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(b)(4).Correction to b5: upon further clarification the part number/device has been confirmed as iw900 pcb assay control manual.Method: the complaint iw900 pcb assay control manual was returned to fisher & paykel healthcare (f&p) in new zealand for investigation, where it was visually inspected and peformance tested.Results: during testing it was noted that the unit's power fail alarm did not function when the unit was disconnected from power.A faulty component on the control pcb could have caused the audio alarm to not function.Conclusion: it is likely that the replaceable super capacitor on the pcb board wore out over time.The super capacitor's function is to store sufficient electrical charge to power the warmer's visual and audible alarms in the event of a failure of mains power.Part of fisher & paykel healthcare's quality control process involves testing the power failure alarm of every warmer on the production line for functionality prior to distribution.The device technical/service manual contains a checklist which specifies that users perform safety, performance and functional checks including the power fail alarm at least once a year.Included in the warmer's maintenance checklist is a test of the super capacitor to ensure it is operating within specifications.
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Search Alerts/Recalls
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