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

Model Number GF-210RA

Device Problems Mechanical Problem (1384); Output Problem (3005)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/24/2019

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer reported that the multigas unit was giving a "device not found - flashed enabled" error message and stated that the fan was not working on the unit.Gas unit was not reading gas numerical values and the error did not disappear.No patient harm 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.Additional model information: concomitant medical device field contains no information (ni), as attempts to obtain information were made, but not provided.

Event Description

The biomedical engineer reported that the multigas unit was giving a "device not found - flashed enabled" error message and stated that the fan was not working on the unit.Gas unit was not reading gas numerical values and the error did not disappear.No patient harm reported.

Manufacturer Narrative

Details of complaint: customer reported that the fan on the multigas unit had malfunctioned.Additionally, they were getting an "error device not found / flash enabled" message from the device at the connected bedside monitor.Because of this, the device could not give gas measurements.The device was sent in for evaluation and exchange.Service requested / performed: exchange / evaluation: nka's repair center evaluated the device.The device gave a "gas device error" message.An investigation was conducted under (b)(4) and concluded that for gf-210ra, revision cb and onward, with sensor unit cd-314p, revision 2 (serial numbers (b)(6) to (b)(6) needed a firmware upgrade.Revision 2 of cd-314p utilizes a new pump with a slight difference in specification.The sensor unit detects this small difference and output as the "gas device error" message.The countermeasure is to perform a firmware upgrade.The firmware was updated on 02/26/2020.The device performed per specifications.Investigation summary: the overall risk score is high.The root cause is determined to be incompatible software with sensor unit cd-314p.The firmware update resolved the issue.Hha-19-010a was conducted to assess health impact.The following fields are not applicable (na) to the mdr report: b2.B6.B7.D4 lot # & expiration date.D6a & d6b.D7b.F1 - f14.G4 device bla number.G5.G7.H7.H9.The following fields contain no information (ni), as attempts to obtain information were made, but not provided: a2 - a6.D10.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.

Event Description

The biomedical engineer reported that the multigas unit was giving a "device not found - flashed enabled" error message and stated that the fan was not working on the unit.Gas unit was not reading gas numerical values and the error did not disappear.No patient harm 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
• MDR Report Key: 9332029
• MDR Text Key: 200654949
• Report Number: 8030229-2019-00663
• Device Sequence Number: 1
• Product Code: CCK
• UDI-Device Identifier: 04931921106891
• UDI-Public: 04931921106891
• Combination Product (y/n): N
• PMA/PMN Number: K110594
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 11/15/2019,08/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2019
• 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: 11/05/2019
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/15/2019
• Distributor Facility Aware Date: 10/24/2019
• Device Age: 9 MO
• Event Location: Hospital
• Date Report to Manufacturer: 11/15/2019
• Date Manufacturer Received: 06/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1