Model Number GF-210RA |
Device Problem
Output Problem (3005)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/07/2022 |
Event Type
malfunction
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Event Description
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The customer reported that they're barely getting any co2 reading on the multigas unit.There was no patient injury reported.
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Manufacturer Narrative
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The customer reported that they're barely getting any co2 reading on the multigas unit.According to the customer, they had to "scale" it up a ton to be able to see anything.The customer is no longer able to read co2 monitoring data.Technical support (ts) advised the customer to exchanged the unit as it cannot be repaired.There was no patient injury 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 customer reported that they're barely getting any co2 reading on the multigas unit.There was no patient injury reported.
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Manufacturer Narrative
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Details of complaint: the customer reported that they're barely getting any co2 reading on the multigas unit.According to the customer, they had to "scale" it up a ton to be able to see anything.The customer is no longer able to read co2 monitoring data.Technical support (ts) advised the customer to exchanged the unit as it cannot be repaired.There was no patient injury reported.Investigation summary: the root cause is determined to be component failure: sensor needed replacement.Sensor is a replaceable component, where the longevity is dependent upon the following factors: · instrument and parts must undergo regular maintenance inspection at least every 6 months.· if stored for extended periods without being used, make sure prior to operation that the instrument is in perfect operating condition.Manufacturer references # (b)(4) follow up 001.
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Search Alerts/Recalls
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