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

Model Number GF-210RA

Device Problems Sensing Intermittently (1558); Device Sensing Problem (2917); Power Problem (3010); Intermittent Loss of Power (4016)

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

Event Date 10/24/2019

Event Type  malfunction  

Manufacturer Narrative

The customer reported that the multigas unit failed intermittently during a case.The customer also reported that the unit stopped working out of nowhere and then came back randomly.The device was in use on a patient, but no patient harm was reported.They will be sending the unit in for an exchange.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 failed intermittently during a case.

Manufacturer Narrative

Details of complaint: the customer reported that the multigas unit intermittently stopped reading the gases.The customer explained that the doctors have complained it will stop working out of nowhere and then come back randomly.No patient harm was reported.Service requested / performed: exchange / evaluation.Investigation summary: the overall risk score is medium.The root cause is determined to be component failure: a sensor needed replacement.The sensor is a replaceable component, where the longevity is dependent upon the following factors: instrument and parts must undergo regular maintenance inspection at least every 6 months.If stored for extended periods without being used, make sure prior to operation that the instrument is in perfect operating condition.Water trap should be replaced every 4 weeks or as indicated on the device.Ensuring the environment is optimal as described in the operator's manual.Based on sop07-003, no capa is required as the quality event does not warrant a corrective action.Corrected information: h6 labeled for single use?: corrected the selection from "yes" to "no.".

Event Description

The customer reported that the multigas unit failed intermittently during a case.

• 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: 9312750
• MDR Text Key: 200655498
• Report Number: 8030229-2019-00651
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 11/12/2019,08/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2019
• 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: 12/19/2019
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/12/2019
• Distributor Facility Aware Date: 10/24/2019
• Device Age: 14 MO
• Event Location: Hospital
• Date Report to Manufacturer: 11/12/2019
• Date Manufacturer Received: 06/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1