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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 Failure to Sense (1559); Device Issue (2379); Device Sensing Problem (2917)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/30/2018
Event Type  malfunction  
Manufacturer Narrative
The customer reported that the unit does not read co2. The unit was used on a previous patient and it operated just fine. Customer reports that the unit stopped reading co2 while prepping for the next patient. Customer is sending the unit in for repair. 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 unit does not read co2.
 
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Brand NameGF-210RA
Type of DeviceMULTI-GAS UNIT
Manufacturer (Section D)
NIHON KOHDEN CORPORATION
1-31-4 nishiochia, shinjuku-ku
attn: shama mooman
tokyo, 161-8 560
JA 161-8560
Manufacturer (Section G)
NIHON KOHDEN TOMIOKA CORPORATION
1-1 tajino
attn: shama mooman
tomioka city, 370-2 314
JA 370-2314
Manufacturer Contact
shama mooman
safety mgmt dept, quality mgmt
seibu bldg 2, 4th floor 1-11-2
kusunokidai tokorozawa, saitama 359-8-580
JA   359-8580
MDR Report Key7465430
MDR Text Key106719334
Report Number8030229-2018-00134
Device Sequence Number1
Product Code CCK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K110594
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 01/21/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/26/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberGF-210RA
Device Catalogue NumberGF-210RA
Device Lot NumberNOT APPLICABLE
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/19/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/21/2020
Distributor Facility Aware Date01/17/2020
Device Age48 MO
Event Location Hospital
Date Report to Manufacturer01/21/2020
Date Manufacturer Received01/17/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/08/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Removal/Correction NumberNOT APPLICABLE

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