Model Number GZ-130PA |
Device Problems
Application Program Problem (2880); Unintended Application Program Shut Down (4032)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/24/2023 |
Event Type
malfunction
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Manufacturer Narrative
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The biomedical engineer reported that the telemetry transmitter (tele) is constantly rebooting.They have already tried to troubleshooting the unit and was unable to resolve the issue.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.
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Event Description
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The biomedical engineer reported that the telemetry transmitter (tele) is constantly rebooting.They have already tried to troubleshooting the unit and was unable to resolve the issue.No patient harm was reported.
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Manufacturer Narrative
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Details of the complaint: the biomedical engineer reported that the telemetry transmitter (tele) is constantly rebooting.They have already tried to troubleshooting the unit and was unable to resolve the issue.No patient harm was reported.Investigation conclusion: the complaint unit was returned and was evaluated.The device was not turning on.Nk repair center was unable to observe the constant reboot issue due to the device not turning on.The batteries of the device were replaced but the device would still not turn on.Nk repair center noted that the battery port has "heavy corrosion".The corrosion at the battery port is likely causing the constant reboot and power issues on the device.The corrosion on the battery port is likely caused by fluid intrusion.Residual moisture on the device could have dried up and had caused the corrosion of the battery port.Per operator's manual of the device, the device is waterproof but the battery case, electrode lead, and spo2 probe are not waterproof.
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Event Description
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The biomedical engineer reported that the telemetry transmitter (tele) is constantly rebooting.They have already tried to troubleshooting the unit and was unable to resolve the issue.No patient harm was reported.
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Search Alerts/Recalls
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