Model Number GZ-120PA |
Device Problem
Application Program Problem (2880)
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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 07/24/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The biomedical engineer reported that the gz transmitter discharged the patient, possibly without user intervention.They were not sure if a staff member manually discharged the patient.Nk ts asked that they provide the cns logs in order to perform an investigation, however nk has not yet received the logs.No patient harm was reported.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.The following field contains no information (ni), as attempts to obtain information were made, but not provided: concomitant medical products.
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Event Description
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The biomedical engineer reported that the gz transmitter discharged the patient, possibly without user intervention.
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Event Description
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The biomedical engineer reported that the gz transmitter discharged the patient, possibly without user intervention.
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Manufacturer Narrative
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Details of complaint: the biomedical engineer reported that the gz transmitter discharged the patient, possibly without user intervention.They were not sure if a staff member manually discharged the patient.No patient harm or injury was reported.Investigation summary: the customer stated they were unsure if the patient was discharged on the remote network station (rns) as well as the central nurse's station (cns).Nihon kohden technical support (nk ts) requested event logs, and the customer stated they would call back if it happened again.Follow-up correspondence for information did not receive a reply.With the information available it is reasonable to determine the root cause to be man (user education).A review of the serial number history shows no recurrence of the reported event.Admitting patients and inputting their patient information can be done on the transmitter as long as the previous patient has been discharged through the "discharging a patient" section.
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Search Alerts/Recalls
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