Model Number ZM-521PA |
Device Problems
Display or Visual Feedback Problem (1184); Application Program Problem: Dose Calculation Error (1189); Communication or Transmission Problem (2896); Output Problem (3005); Intermittent Communication Failure (4038)
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Patient Problems
No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/11/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The customer reported that their multi-gas unit was displaying "cal error" alarms.The device also displayed "gas unspecified accuracy," and the customer reported the co2 reading to be about half of what it should have been.The customer tried changing the water trap and dry line, but the issue remained.He replaced the unit with another backup on hand.The customer received a loaner device and is sending in the defective device for repair.Nihon kohden continues to investigate the reported event.Nihon kohden will submit a supplemental report in accordance with 21 cfr section 803.56 when additional information becomes available.
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Event Description
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The customer reported that their multi-gas unit was displaying "cal error" alarms.The device also displayed "gas unspecified accuracy," and the customer reported the co2 reading to be about half of what it should have been.
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Event Description
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The customer reported that the telemetry transmitters on two floors went into comm loss at the central nurse's station (cns) and the remote network station (rns).
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Manufacturer Narrative
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Details of complaint: the customer reported that the telemetry transmitters on two floors went into signal loss at the central nurse's station (cns) and the remote network station (rns).No patient harm or injury was reported.Investigation summary: as the reported device was not returned for evaluation, a root cause cannot be determined.On-site support was sent to the customer responding to a different complaint to rebalance the antenna system to resolve the issue.A complaint history review of the customer's account reveals additional complaint reporting of signal loss.These events were reported to be intermittent.As such, it is likely that the signal loss was caused by environmental factors that interfere with wmts frequencies.There is no evidence that a nihon kohden device malfunctioned.
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Search Alerts/Recalls
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