Model Number GF-210RA |
Device Problem
Application Program Problem (2880)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/07/2022 |
Event Type
malfunction
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Manufacturer Narrative
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The customer reported that the multigas unit displayed a "gas device failure" message.According to the customer, the unit is not able to take any readings.The customer will send in the unit to be exchanged.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 the multigas unit displayed a "gas device failure" message.There was no patient injury reported.
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Manufacturer Narrative
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Details of complaint: the customer reported that the multigas unit displayed a "gas device failure" message.According to the customer, the unit is not able to take any readings.The customer will send in the unit to be exchanged.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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Event Description
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The customer reported that the multigas unit displayed a "gas device failure" message.There was no patient injury reported.
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Search Alerts/Recalls
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