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

Model Number GF-210RA

Device Problem Data Problem (3196)

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

Event Date 01/10/2024

Event Type  malfunction  

Manufacturer Narrative

The customer reported that this multigas unit was not producing any gas readings.According to the customer, the unit stopped producing readings to the bedside monitor (bsm).The customer changed out the unit with a know working unit.The customer will send in the unit to be exchanged.There was no patient injury reported.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 attempts to obtain information were made, but not provided: a2 - a6 attempt # 1: 01/12/2024 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 01/15/2024 emailed the customer via microsoft outlook for patient information: the customer replied by stating; i'm unable to provide the patient information.Attempt # 1: 01/12/2024 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 01/15/2024 emailed the customer via microsoft outlook for patient information: the customer replied by stating; i'm unable to provide the patient information.B7 attempt # 1: 01/12/2024 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 01/15/2024 emailed the customer via microsoft outlook for patient information: the customer replied by stating; i'm unable to provide the patient information.Additional model information: d10 concomitant medical device: the following device was used in conjunction with the gf-210ra: bsm: model #: ni serial #: (b)(6).Device manufacturer date: ni unique identifier (udi) #: (b)(6).Returned to nihon kohden: no.

Event Description

The customer reported that this multigas unit was not producing any gas readings.There was no patient injury.

Manufacturer Narrative

Details of complaint: the customer reported that the multigas unit stopped producing gas readings at the bedside monitor (bsm).The customer swapped out the unit with a known working one.No patient harm was reported.Investigation summary: the reported device was sent in for evaluation and an exchange.The reported issue was confirmed.Upon nihon kohden repair center's (nk rc) evaluation, the unit powered up and immediately displayed a gas line block error message and a gas device error message.Although a definitive root cause could not be determined.Repair center replaced the pump and the main board as preventative maintenance.To resolve the issue, an exchange unit (gf-210ra, sn: (b)(6)) was successfully shipped to the customer.Intermittent readings are related to the settings on the monitoring device in which gf-210ra is connected to.Additionally, a gas reading cannot be obtained when the measurement system is not properly connected.The customer can be advised to use troubleshooting steps in the gf210ra operator's manual, 0614-905501e and can be provided with technical support by our nk ts team as needed.A serial number review of the reported device (model: gf-210ra, sn: (b)(6)) does not reveal additional related complaints.A complaint history review of the customer's account does not reveal trends for similar complaints.The following fields contain no information (ni), as attempts to obtain the information were made, but not provided: a2 - a6 b6 - b7 d10 attempt # 1: 01/12/2024 emailed the customer via microsoft outlook for all information in the ni list: no reply was received.Attempt # 2: 01/15/2024 emailed the customer via microsoft outlook for all information in the ni list: the customer replied, stating they were unable to provide the requested information.Additional model information: d10 concomitant medical device: the following device was used in conjunction with the multgas unit: bsm: model #: ni serial #: ni device manufacturer date: ni unique identifier (udi) #: ni returned to nihon kohden: na.

Event Description

The customer reported that the multigas unit was not producing gas readings.No patient harm was reported.

• 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: 18651611
• MDR Text Key: 334673898
• Report Number: 8030229-2024-04069
• Device Sequence Number: 1
• Product Code: CCK
• 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
• Report Date: 02/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2024
• 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: 01/29/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/19/2022
• 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; BSM