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

Model Number GF-210RA

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Low Test Results (2458); Device Operational Issue (2914); Output Problem (3005)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/19/2018

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer reported that the multigas unit was giving low readings.They replaced the water trap and the sample line.The device was returned to nihon kohden and evaluated.During testing the gas unit gave a constant "check water trap" error message.The device was connected to multiple bedside monitors.It was determined that the device needs a new gas sensor unit.The part is no longer available from nkc.The device cannot be repaired locally and will be returned to the manufacturer for repair.

Event Description

The biomedical engineer reported that the multigas unit was giving low readings.

Event Description

The biomedical engineer reported that the multigas unit was giving low readings.

Manufacturer Narrative

Details of complaint: on (b)(6) 2018, customer reported gas unit was giving low readings.The reading values and the expected values are not known.Customer had replaced water trap and sampling line.No error messages were reported.Service requested: exchange.Service performed: exchange.Investigation result: nka repair center evaluated the exchanged device.Device shows "check water trap".It was determined that a new sensor is required to fix the issue.Per gf-210r operator's manual, revision e, water traps are to be replaced at minimum every four weeks or when the "check watertrap" message appears on the screen.If not, water penetration of the sensor may damage or cause accuracy issues.The maintenance and usage information regarding this device is not available.Therefore, it is not possible to determine the root cause of the sensor failure.Review of the device history record (dhr) shows that the unit has no history of ncmr, refurbishing, or other suspected defects.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.

• 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: 7274357
• MDR Text Key: 100281947
• Report Number: 8030229-2018-00044
• 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: user facility
• Type of Report: Initial,Followup
• Report Date: 10/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2018
• 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: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2018
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/11/2019
• Distributor Facility Aware Date: 10/04/2019
• Device Age: 33 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/11/2019
• Date Manufacturer Received: 10/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NOT APPLICABLE
• Patient Sequence Number: 1