MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION GF-210RA; MULTI-GAS UNIT

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.

• 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 Key: 8075315
• MDR Text Key: 127870588
• Report Number: 8030229-2018-00440
• Device Sequence Number: 1
• Product Code: CCK
• UDI-Device Identifier: 04931921106891
• UDI-Public: 4931921106891
• Combination Product (y/n): N
• PMA/PMN Number: K110594
• Number of Events Reported: 1
• 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 Number: GF-210RA
• Device Catalogue Number: GF-210RA
• Device Lot Number: NOT APPLICABLE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2018
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/21/2020
• Distributor Facility Aware Date: 01/17/2020
• Device Age: 38 MO
• Event Location: Hospital
• Date Report to Manufacturer: 01/21/2020
• Initial Date Manufacturer Received: 10/22/2018
• Initial Date FDA Received: 11/15/2018
• Supplement Dates Manufacturer Received: 01/17/2020
• Supplement Dates FDA Received: 01/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NOT APPLICABLE
• Patient Sequence Number: 1