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

Model Number GF-210RA

Device Problems No Device Output (1435); Output Problem (3005)

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

Event Date 08/01/2023

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer (bme) reported that the multigas unit was not reading any of the gases, no waves or numerics were present according to the medical staff.Sampling line and water trap were changed, but no change.The bme put a different multigas unit in place and everything came back up.No patient harm was reported.The customer sent in the multigas unit to nihon kohden for inspection and repair.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.Additional model information: d10 concomitant medical device: the following device(s) was used in conjunction with the multigas unit: bedside monitor: model #: gf-192ra, serial #: (b)(6), device manufacturer data: 07/10/2019, unique device identifier (udi) #: (b)(4).

Event Description

The biomedical engineer (bme) reported that the multigas unit was not reading any of the gases, no waves or numerics were present according to the medical staff.Sampling line and water trap were changed, but no change.The bme put a different multigas unit in place and everything came back up.No patient harm was reported.The customer sent in the multigas unit to nihon kohden for inspection and repair.

Event Description

The biomedical engineer (bme) reported that the multigas unit was not reading any of the gases, no waves or numerics were present according to the medical staff.Sampling line and water trap were changed, but no change.The bme put a different multigas unit in place and everything came back up.No patient harm was reported.The customer sent in the multigas unit to nihon kohden for inspection and repair.

Manufacturer Narrative

Details of complaint: the biomedical engineer (bme) reported that the multigas unit was not reading any of the gases, no waves or numerics were present according to the medical staff.Sampling line and water trap were changed, but no change.The bme put a different multigas unit in place and everything came back up.No patient harm was reported.The customer sent in the multigas unit to nihon kohden for inspection and repair.Investigation summary: nihon kohden (nk) repair center (rc) evaluated the device and could not duplicate the complaint.Nkrc found that the top cover had extensive cosmetic damage and that there was no fluid intrusion detected.The pump was replaced as a preventative measure, and the software and firmware were upgraded to repair the device.A definitive root cause could not be determined since we could not duplicate the complaint.Possible causes may include hardware component failure or user error with device set-up.Hardware component failure can occur through physical damage from user mishandling, 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.User errors with device set-up may include loose cable connections or incorrect measurement settings.The customer may refer to the operator's manual for troubleshooting measurement settings.Due to the age of the device, wear-and-tear may be a contributing factor to possible hardware component issues.A review of the customer's complaint history for this issue and device did not reveal any trends.Nk will continue to monitor and trend similar complaints.Additional model information: d10 concomitant medical device: the following device(s) was used in conjunction with the multigas unit: bedside monitor: model #: cu-192ra.Serial #: (b)(6).Device manufacturer data: 07/10/2019.Unique device identifier (udi) #: (b)(4).Additional information: b4 date of this report g3 date received by manufacturer g6 type of report h2 if follow-up, what type? h6 event problem and evaluation codes h10 additional manufacture narrative - correction to additional model information.

• 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: 17627844
• MDR Text Key: 322070648
• Report Number: 8030229-2023-03725
• 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: Health Professional,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: 08/11/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/05/2018
• 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: LIFE SCOPE G9.; LIFE SCOPE G9.