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); Output Problem (3005)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/31/2023

Event Type  malfunction  

Manufacturer Narrative

Biomed emailed reporting that the multi-gas unit had intermittent o2 waveform.There were no error messages, and the wave would disappear/stop registering.Biomed and an anesthesia technician ran a new water trap and co line, but the intermittent waveform happened more than once after a few minutes of the warm-up.There was no malfunction with the bsms it was connected to for testing.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.The following fields contain no information (ni), as the device was not in use with a patient: a2 - a6; b6; b7.Additional model information: d10 concomitant medical device: the following device(s) was used in conjunction with the multigas unit: bedside monitor: model #: mu-631ra / bsm-6301, serial #: (b)(6) , device manufacturer data:04/16/2015, unique identifier (udi) #: (b)(4); bedside monitor: model #: bsm-1753, serial #: (b)(6), device manufacturer data:ni , unique identifier (udi) #:(b)(4).

Event Description

Biomed emailed reporting that the multi-gas unit had intermittent o2 waveform.There were no error messages, and the wave would disappear/stop registering.Not in patient use.

Manufacturer Narrative

Details of complaint: the biomedical engineer (bme) emailed reporting that the multi-gas unit had intermittent o2 waveforms.There were no error messages, and the o2 waveforms would disappear/stop registering.Bme and an anesthesia technician ran a new water trap and co line, but the intermittent waveforms happened more than once after a few minutes of the warm-up.There was no malfunction with the bedside monitors (bsms) it was connected to for testing.Not in use with a patient.Investigation summary: the gf-210ra multi-gas unit was returned and evaluated.Nihon kohden repair center (nk rc) was unable to duplicate/observe the reported issue (intermittent o2 waveform).Nk rc found a potentially different issue with the pump of the device, as it is making a rattling noise.Nk rc indicated that they were unable to repair the device as it is an older gas module.An exchange device was sent to the customer to replace the complaint unit.The reported issue (intermittent o2 waveform) could not be confirmed.This suggests that the issue is unlikely due to failure of the device.The root cause of the issue could not be identified.The issue may be related to the water trap, gas line, cables, and their connection to the gf-210ra muli-gas unit.The device has been in service since 10/11/2015.Wear and tear may also be a contributing factor to the issue.The reported issue could not be confirmed.No corrective actions would be performed at this time.Nk will continue to trend and monitor the reported issue.Additional model information: d10 concomitant medical device: the following devices were used in conjunction with the multi-gas unit: bedside monitor / bsm-6301.Model #: mu-631ra.Serial #: (b)(6).Device manufacturer data: 16/04/2015.Unique identifier (udi) #: (b)(4).Bedside monitor: model #: bsm-1753.Serial #: (b)(6).Device manufacturer data: 22/08/2014.Unique identifier (udi) #:(b)(4).

Event Description

The biomedical engineer (bme) emailed reporting that the multi-gas unit had intermittent o2 waveforms.There were no error messages, and the o2 waveforms would disappear/stop registering.Not in patient use.

• 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 Key: 16791950
• MDR Text Key: 314052319
• Report Number: 8030229-2023-03486
• Device Sequence Number: 1
• Product Code: CCK
• UDI-Device Identifier: 04931921106891
• UDI-Public: 04931921106891
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110594
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 07/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2023
• 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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/19/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: BSM-1700; BSM-1700; BSM-6000; BSM-6000