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

Model Number GF-210RA

Device Problems Application Program Problem (2880); Output Problem (3005); Unintended Application Program Shut Down (4032)

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

Event Date 06/14/2022

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer reported that the multigas unit was giving a co2 malfunction error message, and it would not let them take readings.They changed the water trap and rebooted the unit, but the error persisted.They also said that the unit will randomly shut off as well.No patient harm 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 biomedical engineer reported that the multigas unit was giving a co2 malfunction error message, and it would not let them take readings.They changed the water trap and rebooted the unit, but the error persisted.They also said that the unit will randomly shut off as well.No patient harm was reported.

Manufacturer Narrative

Details of the complaint: the biomedical engineer reported that the multigas unit was giving a co2 malfunction error message, and it would not let them take readings.They changed the water trap and rebooted the unit, but the error persisted.They also said that the unit will randomly shut off as well.No patient harm was reported.Investigation conclusion: based on the operator's manual, known causes for no readings are related to incorrect settings or use error.The customer's complaint history suggests that the facility has a history of having 'no co2 readings' issues due to improper use of the gf-201ra device.The customer has a history of using non specified components to be used with the gf-210ra.Root cause is likely related to use error.This issue will be trended as additional education may be necessary should this issue recur with the exchange device.The cause of random shutoff is likely related to hardware failure due to physical damage or overheating due to improper device placement or failure to perform proper maintenance as specified in the operator's manual for gf-210ra.The reported issues of no readings and power loss are unlikely to be related to device deficiencies.The following fields are not applicable (na) to the mdr report: d4: lot number & expiration.G4: device bla number.Additional device information: d10: concomitant medical device field contains no information (ni), as attempts to obtain information were made, but not provided.Additional information: b4: date of this report.D9: device available for evaluation.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 co2 malfunction error message, and it would not let them take readings.They changed the water trap and rebooted the unit, but the error persisted.They also said that the unit will randomly shut off as well.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 ; 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: 15022474
• MDR Text Key: 296224014
• Report Number: 8030229-2022-02953
• 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: 09/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2022
• 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: 09/12/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/06/2020
• 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: NI.; NI.