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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 Erratic or Intermittent Display (1182); Output Problem (3005)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/08/2020
Event Type  malfunction  
Manufacturer Narrative
The biomedical engineer reported that the multigas unit was reading gases intermittently while in patient use, no patient harm was reported.This incident occurred on (b)(6) 2020 but the user facility biomedical engineer did not report it to nihon kohden until 05/12/2021.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.Attempt # 1: (b)(6) 2021: emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: (b)(6) 2021: emailed the customer via microsoft outlook for patient information: no reply was received.Importer reference file (b)(4).
 
Event Description
The biomedical engineer reported that the multigas unit was reading gases intermittently while in patient use, no patient harm was reported.This incident occurred on (b)(6) 2020 but the user facility biomedical engineer did not report it to nihon kohden until 05/12/2021.
 
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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 Key11987599
MDR Text Key271082970
Report Number2080783-2021-00331
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 Biomedical Engineer
Type of Report Initial
Report Date 06/11/2021,05/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/11/2021
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? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/11/2021
Distributor Facility Aware Date05/12/2021
Event Location Hospital
Date Report to Manufacturer06/11/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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