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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 Stops Intermittently (1599)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 05/16/2017
Event Type  malfunction  
Manufacturer Narrative
The customer reported that the multi gas unit had no end tidal co2 readings. Nihon kohden's technical services advised that the correct cable was not in use. The unit constantly tried to recalibrate causing waveforms to flat-line then disappear. Clearing the water trap helped, but the unit worked only intermittently. The unit was in use on a patient, but no patient harm was reported. The customer sent the unit in and the unit was evaluated by nihon kohden. After extended testing was performed, the reported problem of "intermittent issues with showing entidal co2" was not duplicated, however the gas unit was replaced for precautionary measure. The unit was tested per operator's/service manual and the unit completed 24 hours of extended testing and operates to manufacturer's specifications.
 
Manufacturer Narrative
The customer reported that the multigas unit had no end tidal co2 readings. Nihon kohden's technical services advised that the correct cable was not in use. The unit constantly tried to recalibrate causing the waveforms to flat-line then disappear. Clearing the water trap helped, but the unit worked only intermittently. The unit was in use on a patient, but no patient harm was reported. The customer sent the unit in and it is currently awaiting evaluation. Nihon kohden continues to investigate the reported event. Nihon kohden will submit a supplemental report in accordance with 21 cfr section 803. 56 if additional information becomes available.
 
Event Description
The customer reported that the multigas unit had no end tidal co2 readings.
 
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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, japan 161-8 560
JA 161-8560
Manufacturer (Section G)
NIHON KOHDEN TOMIOKA CORPORATION
1-1 tajino
attn: shama mooman
tomioka city, gunma 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
2687488
MDR Report Key6632455
MDR Text Key119709060
Report Number8030229-2017-00190
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
Type of Report Initial,Followup
Report Date 06/09/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/09/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberGF-210RA
Device Catalogue NumberGF-210RA
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/01/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Report Sent to FDA06/09/2017
Distributor Facility Aware Date05/16/2017
Device Age44 MO
Event Location Hospital
Date Report to Manufacturer06/09/2017
Date Manufacturer Received06/09/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/22/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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