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

Model Number GF-210RA

Device Problems Failure to Power Up (1476); Electrical Power Problem (2925); Unexpected Shutdown (4019)

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

Event Date 09/28/2021

Event Type  malfunction  

Manufacturer Narrative

The customer reported that the multigas unit is no longer turning on.Per the customer, the unit lost power during patient use.The customer will send in the unit for exchange.There was no patient injury reported.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.

Event Description

The customer reported that the multigas unit lost power during patient use and it is no longer turning on.No patient harm was reported.

Manufacturer Narrative

The customer reported that the multigas unit lost power during patient use and was no longer powering on.The customer sent the unit in for exchange.The unit was sent in for an exchange.No patient harm was reported.Investigation summary: the unit was sent in and evaluated, but the reported issue of losing power could not be duplicated.The gf-210ra operator's manual, 0614-905501e, provides the following information regarding power requirements and connecting the power cord.If the power is cut off for longer than 30 seconds, the gas unit will power up once power is restored.The initialization sequence is restarted.The manual stated that if the user does not see the power light on the front panel, the user should check to ensure the power cord is properly seated in the back and at the wall outlet.Based on the events of this incident, it is unknown whether there was a device failure or a setup failure.No troubleshooting details were available to rule out that a set up error was not causing the reported issue.There is no information to determine if there has been a device malfunction.The service history for gf-210ra s/n (b)(6) and the service history for this facility shows this is an isolated incident for gf-210ra not powering on.

Event Description

The customer reported that the multigas unit lost power during patient use and was no longer powering on.No patient harm was reported.

• 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: 12705020
• MDR Text Key: 279103340
• Report Number: 8030229-2021-01858
• 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: 03/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2021
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/11/2018
• 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