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

Model Number GF-210RA

Device Problem Output Problem (3005)

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

Event Date 07/28/2023

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer (bme) reported the unit measures desflurane (des), intermittently measures sevoflurane (sevo), does not measure isoflurane (iso).They found this issue while performing routine maintenance.The desflurane from the vaporizer would be measured and displayed on the bsm as des and was used in a case prior to my testing.The des was still holding a position / slot on the bedside monitor (bsm).The sevo and iso vaporizers were not in use at the time but are available.The bme was using a calibration gas: consisting of 1% isoflurane, 1% sevoflurane ,5% co2, 70% n2o and balance of o2 to check the operation of the gf-210ra.The sevo measured and displayed some of the time; the sevo value would blank out when not reading.There was no error message when it did this.The iso would not measure and display at all.The calibration gas is okay as it has been used to measure values on other gf-210ra pre and post the testing of this device in question.Not in patient use.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 are not applicable (na) to the mdr report: a2 - a6 b2 b6 - b7 d4 lot number & expiration d6a - d6b d7b f1 - f14 g4 device bla number g5 g7 h2 h7 h9 additional device information: d10 concomitant medical device bedside monitor model: bsm-6701a sn: 02119 input unit model: ay-653p sn: 08107.

Event Description

The biomedical engineer (bme) reported the unit measures desflurane (des), intermittently measures sevoflurane (sevo), does not measure isoflurane (iso).They found this issue while performing routine maintenance.The desflurane from the vaporizer would be measured and displayed on the bsm as des and was used in a case prior to my testing.The des was still holding a position / slot on the bedside monitor (bsm).The sevo and iso vaporizers were not in use at the time but are available.The bme was using a calibration gas: consisting of 1% isoflurane, 1% sevoflurane ,5% co2, 70% n2o and balance of o2 to check the operation of the gf-210ra.The sevo measured and displayed some of the time; the sevo value would blank out when not reading.There was no error message when it did this.The iso would not measure and display at all.The calibration gas is okay as it has been used to measure values on other gf-210ra pre and post the testing of this device in question.Not in patient use.

Event Description

The biomedical engineer (bme) reported the unit measures desflurane (des), intermittently measures sevoflurane (sevo), does not measure isoflurane (iso).They found this issue while performing routine maintenance.The desflurane from the vaporizer would be measured and displayed on the bsm as des and was used in a case prior to my testing.The des was still holding a position / slot on the bedside monitor (bsm).The sevo and iso vaporizers were not in use at the time but are available.The bme was using a calibration gas: consisting of 1% isoflurane, 1% sevoflurane ,5% co2, 70% n2o and balance of o2 to check the operation of the gf-210ra.The sevo measured and displayed some of the time; the sevo value would blank out when not reading.There was no error message when it did this.The iso would not measure and display at all.The calibration gas is okay as it has been used to measure values on other gf-210ra pre and post the testing of this device in question.Not in patient use.

Manufacturer Narrative

Details of the complaint: the biomedical engineer (bme) reported the unit measures desflurane (des), intermittently measures sevoflurane (sevo), does not measure isoflurane (iso).They found this issue while performing routine maintenance.The desflurane from the vaporizer would be measured and displayed on the bsm as des and was used in a case prior to my testing.The des was still holding a position / slot on the bedside monitor (bsm).The sevo and iso vaporizers were not in use at the time but are available.The bme was using a calibration gas: consisting of 1% isoflurane, 1% sevoflurane ,5% co2, 70% n2o and balance of o2 to check the operation of the gf-210ra.The sevo measured and displayed some of the time; the sevo value would blank out when not reading.There was no error message when it did this.The iso would not measure and display at all.The calibration gas is okay as it has been used to measure values on other gf-210ra pre and post the testing of this device in question.Not in patient use.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.Service performed and investigation conclusion: an exchange was processed for the customer.Nihon kohden (nk) received the complaint device on 08/08/2023.Nk repair center (rc) evaluated the device on 11/15/2023 and could not duplicate the complaint.Nk rc found that when the unit powers on it makes a loud clicking noise, and that it operates to manufacturer specifications.A definitive root cause could not be determined since we could not duplicate the complaint, but possible cause may include hardware component failure possibly due to power issues from outages or surges which can affect the integrity of electronic components, or wear-and-tear which depends on device age and frequency of use.Review of the complaint device's serial number shows that the unit has been in service since july 2014 and has no other complaints.Due to the age of the device, wear-and-tear may be a contributing factor to possible hardware component failure.Review of the customer's complaint history shows 2 previous similar complaints under tickets 155884 and 179659 in which we did not duplicate the complaint and physical damage, firmware issues, user error, or lack of maintenance were identified as potential causes.The following fields are not applicable (na) to the mdr report: a2 - a6, b2, b6 - b7, d4 lot number & expiration, d6a - d6b, d7b, f1 - f14, g4 device bla number, g5, g7, h7, h9.Additional device information: d10 concomitant medical device.Bedside monitor.Model: bsm-6701a.Sn: (b)(6).Input unit.Model: ay-653p.Sn: (b)(6).Additional information: b4 date of this report.G3 date received by manufacturer.G6 type of report.H2 if follow-up, what type? 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; 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: 17627832
• MDR Text Key: 322291127
• Report Number: 8030229-2023-03714
• 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: 11/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2023
• 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
• Date Returned to Manufacturer: 08/08/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/04/2014
• 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: AY-653P SN (B)(6). ; AY-653P SN (B)(6). ; BSM-6701A SN (B)(6). ; BSM-6701A SN (B)(6).