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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); Display or Visual Feedback Problem (1184)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/25/2023
Event Type  malfunction  
Event Description
The customer reported that this gas unit is intermittently dropping out when in use.According to the customer, the unit will stop showing waveforms and numerics for a couple of seconds and then they will show again without user intervention.There was no patient injury reported.
 
Manufacturer Narrative
The customer reported that this gas unit is intermittently dropping out when in use.According to the customer, the unit will stop showing waveforms and numerics for a couple of seconds and then they will show again without user intervention.There was no error message seen.The customer put in a different gas unit in place to resolve the issue.The customer will send in the unit to be exchanged.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 this gas unit is intermittently dropping out when in use.According to the customer, the unit will stop showing waveforms and numerics for a couple of seconds and then they will show again without user intervention.There was no patient injury reported.
 
Manufacturer Narrative
Details of complaint: the customer reported that this gas unit is intermittently dropping out when in use.According to the customer, the unit will stop showing waveforms and numerics for a couple of seconds and then they will show again without user intervention.There was no error message seen.The customer put in a different gas unit in place to resolve the issue.The customer will send in the unit to be exchanged.There was no patient injury reported.Investigation summary: nihon kohden (nk) received the complaint device on 09/14/2023.Nk repair center (rc) evaluated the unit on 11/09/2023 and could not duplicate the complaint.Physical evaluation found that the top cover had extensive cosmetic damage.The pump was replaced as a preventative measure and the software was upgraded to 01-07 and firmware rev.04.23.02.The top cover, fan filter, and labels were also replaced.A definitive root cause could not be determined since we could not duplicate the complaint.The following fields contain no information (ni), as attempts to obtain information were attempt # 1: 08/28/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 09/01/2023 emailed the customer via microsoft outlook for patient information: the customer replied by stating; we don't have patient information.B6 attempt # 1: 08/28/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 09/01/2023 emailed the customer via microsoft outlook for patient information: the customer replied by stating; we don't have patient information.B7 attempt # 1: 08/28/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 09/01/2023 emailed the customer via microsoft outlook for patient information: the customer replied by stating; we don't have patient information.Additional model information: d10 concomitant medical device: the following device was used in conjunction with the gf-210ra: bsm: model #: ni.Serial #: ni.Device manufacturer data: ni.Unique identifier (udi) #: ni.Returned to nihon kohden: ni.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
seibu bldg 2, 4th floor 1-11-2
kusunokidai tokorozawa, saitama 359-8-580
JA   359-8580
MDR Report Key17777062
MDR Text Key323767207
Report Number8030229-2023-03771
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 12/15/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/19/2023
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
Date Manufacturer Received12/14/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/10/2019
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
BSM; BSM
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