Model Number GF-210R |
Device Problems
Incorrect, Inadequate or Imprecise Result or Readings (1535); Output Problem (3005)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/24/2022 |
Event Type
malfunction
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Manufacturer Narrative
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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.
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Event Description
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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.
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Event Description
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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.
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Manufacturer Narrative
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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.
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Manufacturer Narrative
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Udi related data quality updates.Corrected information: d1 brand name: corrected the brand name from gf-210ra to gf-210r.D4 additional device information / model #: corrected the model # from gf-210ra to gf-210r.D4 additional device information / catalog #: corrected the catalog # from gf-210ra to gf-210r.D4 additional device information / primary unique device identifier (udi) #: corrected the udi # to include the production identifier (pi) information.This is a correction to the suspect medical device involved in the reported event, specifically the unique device identifier (udi) information in section d of the fda form 3500a.Additional information: b4 data of this report.G6 type of report.H2 if follow up, what type?.
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Event Description
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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.
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Search Alerts/Recalls
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