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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 Unable to Obtain Readings (1516); Output Problem (3005)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/22/2018
Event Type  malfunction  
Manufacturer Narrative
Since no loaner units were available, the customer was provided with an exchange to resolve the issue.No investigation was performed on the failed unit.The unit was not in use on a patient at the time.
 
Event Description
The biomedical engineer (bme) reported that the multigas unit would not display waveform.
 
Manufacturer Narrative
Details of complaint: on (b)(6) 2018 customer stated that the gas unit did not give co2 waveform.Device was sent to nka for evaluation and repair.Nka repair center evaluated the device.Device displayed "device error".Service requested: evaluation and repair.Service performed: evaluation.Investigation result: device was put into service 4/30/2016.Service history for this device shows this is an isolated incident.Information necessary for investigation was not available, specifically: · water trap replacement frequency; · gas settings on bedside monitor.For example, if the screen layout on the bedside monitor is set to fixed mode, are the parameter settings properly configured? · verification of proper connection for the water trap and sampling line; · are the gas units positioned at a permanent location or frequently moved? · if frequently moved, is the multi-link connection cable next to the grounding terminal securely seated with two screws tightened? · are there any bents on the exhaust gas tube? · does the bacterial filter, where the exhaust tube is connected to, conform to 0.2 micrometer pore size? · are the units stored in high humidity locations? · is there adequate space behind the unit for the fan to operate properly? · are there any units placed vertically? if so, did customer orientate the water trap according to manual's instruction? service manual for gf-210r/220r, second edition, printed 2012/09/21 includes the following selected items: general handling precautions: · instrument must receive expert, professional attention for maintenance and repairs.When the instrument is not functioning properly, it should be clearly marked to avoid operation while it is out of order.· 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.Per service manual, regular maintenance and inspection must be performed every six months.The "device error" and having no waveform are attributed to sensor unit cd-314p-01 failure.This repair could not be performed at nka.With little information provided regarding customer's maintenance of the device, the root cause of the sensor failure could not be determined.A review of manufacturer's device history record shows no nonconforming report, no deviation and no corrective and preventative actions associated with this device.Investigation conclusion.The "device error" and having no waveform are attributed to sensor unit cd-314p-01 failure.This repair could not be performed at nka.With little information provided regarding customer's maintenance of the device, the root cause of the sensor failure could not be determined.Additional information: b4.Date of this report; f6.Date user facility/importer became aware of the event; f7.Type of report; f11.Date report sent to fda; f13.Date report sent to manufacturer; g4.Date received by manufacturer; g7.Type of report; h2.If follow-up, what type? ; additional information; device evaluation; h3.Device evaluated by manufacturer; h6.Event problem and evaluation codes; h10.Additional manufacturer narrative.
 
Event Description
The biomedical engineer (bme) reported that the multigas unit would not display waveform.
 
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Brand Name
GF-210RA
Type of Device
MULTI-GAS UNIT
Manufacturer (Section D)
NIHON KOHDEN CORPORATION
1-31-4 nishiochia, shinjuku-ku
attn: shama mooman
tokyo, 161-8 560
JA  161-8560
MDR Report Key8075315
MDR Text Key127870588
Report Number8030229-2018-00440
Device Sequence Number1
Product Code CCK
UDI-Device Identifier04931921106891
UDI-Public4931921106891
Combination Product (y/n)N
PMA/PMN Number
K110594
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Type of Report Initial,Followup
Report Date 01/21/2020
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
Device Lot NumberNOT APPLICABLE
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/27/2018
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/21/2020
Distributor Facility Aware Date01/17/2020
Device Age38 MO
Event Location Hospital
Date Report to Manufacturer01/21/2020
Initial Date Manufacturer Received 10/22/2018
Initial Date FDA Received11/15/2018
Supplement Dates Manufacturer Received01/17/2020
Supplement Dates FDA Received01/21/2020
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberNOT APPLICABLE
Patient Sequence Number1
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