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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 Problem Output Problem (3005)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/07/2022
Event Type  malfunction  
Event Description
The customer reported that they're barely getting any co2 reading on the multigas unit.There was no patient injury reported.
 
Manufacturer Narrative
The customer reported that they're barely getting any co2 reading on the multigas unit.According to the customer, they had to "scale" it up a ton to be able to see anything.The customer is no longer able to read co2 monitoring data.Technical support (ts) advised the customer to exchanged the unit as it cannot be repaired.There was no patient injury reported.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 they're barely getting any co2 reading on the multigas unit.There was no patient injury reported.
 
Manufacturer Narrative
Details of complaint: the customer reported that they're barely getting any co2 reading on the multigas unit.According to the customer, they had to "scale" it up a ton to be able to see anything.The customer is no longer able to read co2 monitoring data.Technical support (ts) advised the customer to exchanged the unit as it cannot be repaired.There was no patient injury reported.Investigation summary: the root cause is determined to be component failure: sensor needed replacement.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.Manufacturer references # (b)(4) follow up 001.
 
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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
Manufacturer (Section G)
NIHON KOHDEN TOMIOKA CORPORATION
attn: shama mooman
1-1 tajino
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
MDR Report Key14017626
MDR Text Key289024210
Report Number8030229-2022-02699
Device Sequence Number1
Product Code CCK
UDI-Device Identifier04931921106891
UDI-Public04931921106891
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 03/08/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
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
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/07/2022
Initial Date FDA Received04/05/2022
Supplement Dates Manufacturer Received02/13/2023
Supplement Dates FDA Received03/08/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/07/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Treatment
NI.; NI.
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