Model Number GF-210RA |
Device Problems
Display or Visual Feedback Problem (1184); Image Display Error/Artifact (1304)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/02/2021 |
Event Type
malfunction
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Manufacturer Narrative
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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 multi-gas unit was giving an error stating "device failure".The customer states they are getting this error constantly as well as "line blocked" and that is not the case.This happened during a patient case, no patient was harmed during this incident.The multi-gas unit was swapped out with a spare unit.The customer is sending in the unit in for exchange.Nihon kohden technician provided the customer with a return authorization number and shipped an exchange unit to the customer.
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Event Description
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The customer reported that the multi-gas unit was giving an error stating "device failure".The customer states they are getting this error constantly as well as "line blocked" and that is not the case.This happened during a patient case, no patient was harmed during this incident.The multi-gas unit was swapped out with a spare unit.The customer is sending in the unit in for exchange.Nihon kohden technician provided the customer with a return authorization number and shipped an exchange unit to the customer.
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Manufacturer Narrative
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The customer reported that the multi-gas unit was giving an error stating "device failure".The customer states they are getting this error constantly as well as "line blocked" and that is not the case.This happened during a patient case, no patient was harmed during this incident.The multi-gas unit was swapped out with a spare unit.The customer is sending in the unit in for exchange.Nihon kohden technician provided the customer with a return authorization number and shipped an exchange unit to the customer.Service performed: nihon kohden repair center received unit wth no physical damage.While testing out the water trap received a "gas device error and line block error on the device.Possible malfunction parts/pcbs: gas module.Nkrc replaced the gas module unit which was tested per the operator's/service manual and operates to manufacturer's specifications.Investigation summary: gas device error is an indication that the gas module has failed.The error corresponds to a failure of the sensor unit.The root cause is determined to be component failure: sensor needed replacement.An investigation by nkc had issued corrective action to the manufacturer of the pump to improve performance and reliability.Gf-210ra (b)(6).And later are equipped with improved pumps.This is a known issue and is linked to wear and tear of the motor.
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Search Alerts/Recalls
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