Model Number GZ-130PA |
Device Problems
Overheating of Device (1437); Temperature Problem (3022)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/14/2023 |
Event Type
malfunction
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Manufacturer Narrative
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The biomedical engineer (bme) reported that the gz telemetry transmitter is experiencing overheating.The bme tried to change settings in attempt to lower temperature or tried changing batteries.However, the problem still persists.It is unknown if the device was in patient use.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 fields are not applicable (na) to the mdr report: a2 - a6.B6 - b7.D4 lot number & expiration.D6a - d6b.D10 concomitant medical device.F1 - f14.G4 device bla number.
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Event Description
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The biomedical engineer (bme) reported that the gz telemetry transmitter is experiencing overheating.The bme tried to change settings in attempt to lower temperature or tried changing batteries.However, the problem still persists.It is unknown if the device was in patient use.
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Manufacturer Narrative
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Details of complaint: the biomedical engineer (bme) reported that the gz telemetry transmitter overheated.The bme tried changing the batteries and the settings in attempt to lower the temperature, but the issue persisted.It was unknown if the device was in patient use.Investigation summary: a definitive root cause could not be identified due to the lack of response from the customer.Without the root cause, countermeasures to prevent recurrence of the issue could not be implemented.Nk will continue to trend and monitor the reported issue.No corrective actions will be performed at this time.
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Event Description
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The biomedical engineer (bme) reported that the gz telemetry transmitter overheated.The bme tried changing the batteries and the settings in attempt to lower the temperature, but the issue persisted.It was unknown if the device was in patient use.
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Search Alerts/Recalls
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