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 03/24/2022

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer reported that the multigas unit was giving incorrect reading(s) while on patient's.The bme stated the device was giving a reading of 2.6 for inspired and 2.4 for expired, but the setting should be set to 1.8.The bme reported that they want to send it into nihon kohden for testing no patient(s) were harmed when this occurred.Nihon kohden technician provided the bme with a return authorization number and sent an exchange unit to the customer.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 patient(s) information: patient # 2: age (b)(6), patient sex - male, patient weight (b)(6), ethnicity - unknown, race - unknown, other relevant history, including pre-existing medical conditions - prostate cancer.Patient # 3 - age - (b)(6), patient sex - male, patient weight (b)(6), ethnicitiy - unknown, race - unknown, other relevant history, including pre-existing medical conditions - smoker, hypertension, myocardial infarction, coronary artery disease, hypersensitivity lung disease, end-stage renal disease.Patient # 4 - age - (b)(6), patient sex - male, patient weight (b)(6), ethnicity - unknown, race - unknown, other relevant history, including pre-existing medical conditions - hypersensitivity lung disease, prostate cancer.Patient # 5 - age - (b)(6), patient sex - male, - patient weight (b)(6), ethnicity - unknown, race - caucasian, other relevant history, including pre-existing medical conditions - dementia, hypothyroid, hypertension, hypersensitivity lung disease.

Event Description

The biomedical engineer reported that the multigas unit was giving incorrect reading(s) on patient's.The bme stated the device was giving a reading of 2.6 for inspired and 2.4 for expired, but the setting should be set to 1.8.The bme reported that they want to sent it into nihon kohden for testing no patient(s) were harmed when this occurred.Nihon kohden technician provided the bme with a return authorization number and sent an exchange unit to the customer.

Event Description

The biomedical engineer (bme) reported that the multigas unit was giving incorrect gas readings.The bme stated the device was giving a reading of 2.6 for inspired and 2.4 for expired and the setting should be set to 1.8, but they could not verify the accuracy of the setting.No patient harm was reported.

Manufacturer Narrative

Details of complaint: the biomedical engineer (bme) reported that the multigas unit was giving incorrect gas readings.The bme stated the device was giving a reading of 2.6 for inspired and 2.4 for expired and the setting should be set to 1.8, but they could not verify the accuracy of the setting.No patient harm was reported.Investigation summary: the reported device was sent in for evaluation.During the evaluation of the reported device, nihon kohden repair center (nk rc) was not able to confirm the reported issue of inaccurate cvo readings.The gas mixture and settings the customer was using was not in line with the recommendations stated in the operator's manual for the device.Testing with proper mixtures and settings found that the unit was operating to manufacturer specifications.The root cause is likely related to use error in regards to settings and gas mixture.There is no evidence of an nk device malfunction that may have contributed to the reported issue.Additional patient(s) information: patient # 2 - a2 age - 79 years, a3 patient sex - male, a4 - patient weight 68kg, a5 ethnicity - unknown, a6 race - unknown, b7 other relevant history, including pre-existing medical conditions - prostate cancer.Patient # 3 - a2 age - 43 years, a3 patient sex - male, a4 - patient weight 62 kg, a5 ethnicitiy - unknown, a6 race - unknown, b7 other relevant history, including pre-existing medical conditions - smoker, hypertension, myocardial infarction, coronary artery disease, hypersensitivity lung disease, end-stage renal disease.Patient # 4 - a2 age - 63 years, a3 patient sex - male, a4 - patient weight 112 kg, a5 ethnicity - unknown, a6 race - unknown, b7 other relevant history, including pre-existing medical conditions - hypersensitivity lung disease, prostate cancer.Patient # 5 - a2 age - 82 years, a3 patient sex - male, a4 - patient weight 117 kg, a5 ethnicity - unknown, a6 race - caucasian, b7 other relevant history, including pre-existing medical conditions - dementia, hypothyroid, hypertension, hypersensitivity lung disease.

• 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; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 14137136
• MDR Text Key: 290001995
• Report Number: 8030229-2022-02764
• 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: 10/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2022
• 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: 04/08/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/21/2016
• 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
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 83 KG