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 07/31/2023

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer (bme) reported that the multi-gas unit would intermittently stop showing the waveforms and numerics.The unit did not display any error messages.Not in patient use.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 field contains no information (ni), as attempts to obtain information were made, but not provided: d10 attempt # 1: 08/02/2023 emailed the bme for the concomitant medical device: no reply was received.Attempt # 2: 08/21/2023 emailed the bme for the concomitant medical device: no reply was received.Attempt # 3: 08/24/2023 emailed the bme for the concomitant medical device: no reply was received.Additional model information: d10 concomitant medical device: the following device was used in conjunction with the multigas unit: bedside monitor: model #: ni.Serial #: ni.Device manufacturer data: ni.Unique identifier (udi) #: ni.Returned to nihon kohden: na.

Event Description

The biomedical engineer (bme) reported that the multi-gas unit would intermittently stop showing the waveforms and numerics.Not in patient use.

Manufacturer Narrative

Details of complaint: the biomedical engineer (bme) reported that the multi-gas unit would intermittently stop showing the waveforms and numerics.The unit did not display any error messages.Not in patient use.Investigation summary: as no devices were returned for evaluation relating to this event, the reported issue could not be duplicated or confirmed.As such, the root cause cannot be determined.The customer was contacted to provide the repair po, but the requests were left unanswered.Possible causes for the device not obtaining readings are likely related to hardware failure of the device's gas module.Hardware failure could come as a result of physical, heat, or electrical damage.Physical damage could occur due to impacts with objects and other surfaces.Heat damage could occur due to improper maintenance or placement.Electrical damage could occur during a power outage or power surge.Wear and tear due to aging or frequency of use can gradually degrade components.The device was installed on 6/30/2017 with no history of servicing.A serial number review of the reported device does not reveal additional related complaints.The following field contains no information (ni), as attempts to obtain information were made, but not provided: 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 manufacturer narrative.

Event Description

The biomedical engineer (bme) reported that the multi-gas unit would intermittently stop showing the waveforms and numerics.Not in patient use.

• 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: 17634956
• MDR Text Key: 322101942
• Report Number: 8030229-2023-03737
• 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: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 11/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2023
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2017
• 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