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

Model Number GF-210RA

Device Problem Unexpected Shutdown (4019)

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

Event Date 07/31/2023

Event Type  malfunction  

Event Description

The customer reported that this unit intermittently shuts off/stops reading waveforms/numerics.There was no patient injury reported.

Manufacturer Narrative

The customer reported that this unit intermittently shuts off/stops reading waveforms/numerics.According to the customer, when this happens, there's no error message on the screen.The customer was able to put a different unit in place.Technical support (ts) sent the customer a quote to have the unit exchanged.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.

Manufacturer Narrative

Details of complaint: the customer reported that this unit intermittently shuts off/stops reading waveforms/numerics.According to the customer, when this happens, there's no error message on the screen.The customer was able to put a different unit in place.Technical support (ts) sent the customer a quote to have the unit exchanged.There was no patient injury reported.Investigation summary: as no devices were returned for evaluation relating to this event, the reported issue could not be duplicated nor confirmed.As such, root cause cannot be determined.The customer stated that they had retired the device from service and would not be returning it for servicing.The following fields contain no information (ni), as attempts to obtain information were made, but not provided: a2 - a6: attempt #1: on 08/10/2023, emailed the customer via microsoft outlook for patient information: no reply was received.Attempt #2: on 08/15/2023, emailed the customer via microsoft outlook for patient information: no reply was received.Attempt #3: on 08/23/2023, emailed the customer via microsoft outlook for patient information: no reply was received.B6: attempt #1: on 08/10/2023, emailed the customer via microsoft outlook for patient information: no reply was received.Attempt #2: on 08/15/2023, emailed the customer via microsoft outlook for patient information: no reply was received.Attempt #3: on 08/23/2023, emailed the customer via microsoft outlook for patient information: no reply was received.B7: attempt #1: on 08/10/2023, emailed the customer via microsoft outlook for patient information: no reply was received.Attempt #2: on 08/15/2023, emailed the customer via microsoft outlook for patient information: no reply was received.Attempt #3: on 08/23/2023, emailed the customer via microsoft outlook for patient information: no reply was received.D10: attempt #1: on 08/10/2023, emailed the customer via microsoft outlook for device information: no reply was received.Attempt #2: on 08/15/2023, emailed the customer via microsoft outlook for device information: no reply was received.Attempt #3: on 08/23/2023, emailed the customer via microsoft outlook for device information: no reply was received.Manufacturer references #300338644-180923 follow up 001.

Event Description

The customer reported that this unit intermittently shuts off/stops reading waveforms/numerics.There was no patient injury 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; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 17643923
• MDR Text Key: 322201518
• Report Number: 8030229-2023-03715
• 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

• 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
• Initial Date Manufacturer Received: 07/31/2023
• Initial Date FDA Received: 08/29/2023
• Supplement Dates Manufacturer Received: 11/07/2023
• Supplement Dates FDA Received: 11/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/11/2014
• 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