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

Model Number GF-210RA

Device Problem Output Problem (3005)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/31/2020

Event Type  malfunction  

Manufacturer Narrative

The customer reported that the multigas unit is displaying a "external device" error message.The customer also reported that after the unit displayed the said error, it shutdown on its own before any troubleshooting could have been initiated.The customer would like to send the failed unit in for an exchange.No harm or injury was 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 is displaying a "external device" error message.

Event Description

The customer reported that the multigas unit is displaying a "external device" error message.

Manufacturer Narrative

Details of complaint: the customer reported that the multigas unit was displaying an "external device" error message.The customer also reported that after the unit displayed the said error, it shut down on its own before any troubleshooting could have been initiated.The customer sent the failed unit in for an evaluation.No harm or injury was reported.Service requested / performed: evaluation / repair: nka repair center evaluated the device.The reported issue was duplicated.It was observed that o-ring had no play.The o-ring should be able to move freely.The issue was resolved by reseating the o-ring.Investigation summary: maintenance bulletin mb-3009 dated february 2020 states that the cause of the o-ring without free-play is due to inappropriate assembly.The bulletin identified affected serial numbers.Gf-210ra s/n (b)(6) is one of the affected units.Action taken: nka contacted customers of the affected serial numbers for service.For serial number (b)(6), customer was contacted on 12/03/2020, after the reported incident.No capa is required at this time.Additional information: b4 date of this report g3 date received by manufacturer g6 type of report h2 if follow-up, what type? h3 device evaluated by manufacturer? h6 event problem and evaluation codes h10 additional manufacturer narrative.

• 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 ; safety mgmt dept, quality mgmt; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 10465861
• MDR Text Key: 204727047
• Report Number: 8030229-2020-00485
• 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: 08/28/2020,01/25/2022

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: 08/12/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/28/2020
• Distributor Facility Aware Date: 07/31/2020
• Device Age: 26 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/28/2020
• Initial Date Manufacturer Received: 07/31/2020
• Initial Date FDA Received: 08/28/2020
• Supplement Dates Manufacturer Received: 01/24/2022
• Supplement Dates FDA Received: 01/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/06/2018
• 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