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 10/19/2022

Event Type  malfunction  

Event Description

The biomedical engineer reported the multigas unit was having a multigas error.The bme doesn't know what the exact error message said because it happened during a surgery and they didn't get a screenshot.No patient harm or device damage involved.The bme left the input unit in the surgery room and that is what they started using for vitals in the meantime.Nihoh kohden technical support let the bme know to return the mulitgas unit to nk for evaluation.

Manufacturer Narrative

The biomedical engineer reported the multigas unit was having a multigas error.The bme doesn't know what the exact error message said because it happened during a surgery and they didn't get a screenshot.No patient harm or device damage involved.The bme left the input unit in the surgery room and that is what they started using for vitals in the meantime.Nihoh kohden technical support let the bme know to return the mulitgas unit to nk for evaluation.The bme stated that they did further testing and found the gf-210ra was the cause of the failure, not the concomitant devices connected to it, so those will not be returned to nka.Service/evaluation performed: unit was received, no physical damage nor fluid intrusion.Verified the complaint: unit powered up and immediately gave a gas line block error.After silencing the alarm, also got a gas device error message.Unit does not provide any readings whatsoever.Pending replacement of the pcbs and gas module.Nihon kohden continues to investigate the reported event.Nihon kohden will submit a supplemental report in accordance with 21 cfr section 803.56 if or when additional information becomes available.The following fields contain no information (ni), as attempts to obtain information were made, but not provided: a2 - a6 b6 b7 attempt # 1: 10/25/2022 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 11/09/2022 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 3: 11/10/2022 customer reply to above request for patient information, states they cannot provide the patient demographics on a2-a6.The bme stated that they did further testing and found the gf-210ra was the cause of the failure, not the concomitant devices connected to it, so those will not be returned to nka.Concomitant medical device: the following device(s) was used in conjunction with the multigas unit: bedside monitor: model #: bsm-1733a, serial #: (b)(4), device manufacturer data: 01/01/2020, unique identifier (udi) #: (b)(4), bedside monitor: bsm-6500 main unit, model #: mu-651ra, serial #: (b)(4), device manufacturer data: 01/01/2020, unique identifier (udi) #: (b)(4).

Manufacturer Narrative

Details of complaint: the biomedical engineer (bme) reported that the multigas unit was having a multigas error.The bme does not know what the exact error message said because it happened during a surgery and they did not get a screenshot.No patient harm or device damage involved.The bme left the input unit in the surgery room and that is what they started using for vitals in the meantime.Nihoh kohden technical support let the bme know to return the mulitgas unit to nk for evaluation.The bme stated that they did further testing and found the gf-210ra was the cause of the failure, not the concomitant devices connected to it, so those will not be returned to nka.Service/evaluation performed: unit was received, no physical damage nor fluid intrusion.Verified the complaint: unit powered up and immediately gave a gas line block error.After silencing the alarm, also got a gas device error message.Unit does not provide any readings whatsoever.The gas module of the device was replaced and unit tested within specifications and was returned to customer.Investigation summary: the causes for gas device error are due to improper maintenance, incompatible tubing/connector, device damage, or sensor needing replacement.In these cases, the failure is unlikely to cause or contribute to serious injuries.Review of the serial number in the nk complaint database of this gas module device found other complaints in the search.No further action is warranted.Additional information: b4 date of this report g3 date received by manufacturer g6 type of report h2 if follow-up, what type? h10 additional manufacturer narrative.

Event Description

The biomedical engineer (bme) reported that the multigas unit was having a multigas error.The bme does not know what the exact error message said because it happened during a surgery and they did not get a screenshot.No patient harm or device damage involved.The bme left the input unit in the surgery room and that is what they started using for vitals in the meantime.Nihoh kohden technical support let the bme know to return the mulitgas unit to nk for evaluation.

• 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 359-8580, jpn, 359-8-580 ; JA 359-8580
• MDR Report Key: 15782247
• MDR Text Key: 307790576
• Report Number: 8030229-2022-03178
• 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: 03/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 10/21/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/19/2022
• Initial Date FDA Received: 11/11/2022
• Supplement Dates Manufacturer Received: 02/20/2023
• Supplement Dates FDA Received: 03/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/22/2020
• 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-1700; BSM-1700; BSM-6500 MAIN UNIT; BSM-6500 MAIN UNIT