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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION GF-210RA; MULTI-GAS UNIT
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NIHON KOHDEN CORPORATION GF-210RA; MULTI-GAS UNIT Back to Search Results
Model Number GF-210RA
Device Problems Display or Visual Feedback Problem (1184); Image Display Error/Artifact (1304)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/02/2021
Event Type  malfunction  
Manufacturer Narrative
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 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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Brand Name
GF-210RA
Type of Device
MULTI-GAS UNIT
Manufacturer (Section D)
NIHON KOHDEN CORPORATION
attn: shama mooman
1-31-4 nishiochia
shinjuku-ku, tokyo 161-8 560
JA  161-8560
MDR Report Key12879679
MDR Text Key285677664
Report Number2080783-2021-02020
Device Sequence Number1
Product Code CCK
UDI-Device Identifier04931921106891
UDI-Public04931921106891
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/26/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberGF-210RA
Device Catalogue NumberGF-210RA
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/15/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/26/2021
Distributor Facility Aware Date11/02/2021
Device Age43 MO
Event Location Hospital
Date Report to Manufacturer11/26/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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