Model Number GF-210RA |
Device Problem
Output Problem (3005)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 12/15/2020 |
Event Type
malfunction
|
Manufacturer Narrative
|
The customer reported that their multigas unit is displaying a "gas device failure" error when it's in use.The customer also reported that the device pump is not turning on.No harm or injury was reported.They will be sending this unit in for an exchange.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.
|
|
Event Description
|
The customer reported that their multigas unit is displaying a "gas device failure" error when it's in use.
|
|
Event Description
|
The customer reported that the multigas unit was displaying a "gas device failure" error message while in patient use.The customer also reported that the device pump was not turning on.
|
|
Manufacturer Narrative
|
Details of complaint: the customer reported that the multigas unit was displaying a "gas device failure" error message while in patient use.The customer also reported that the device pump was not turning on.They sent this unit in for an exchange.No patient harm was reported.Service requested / performed: exchange/evaluation.Investigation summary: the root cause is determined to be component failure.The sensor needed replacing.The 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.Water trap should be replaced every 4 weeks or as indicated on the device.Ensuring the environment is optimal as described in the operator's manual.
|
|
Search Alerts/Recalls
|