MAUDE Adverse Event Report: AG-920RA; MULTI-GAS UNIT

Model Number	AG-920RA
Medical Device Problem Code	Calibration Problem (2890)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported that the multigas unit displayed "calibration" error while in patient use.The customer also reported that the etco2 and o2 reading were low.They replaced the dry line water trap 2 days prior to this event and they allowed the device to warm up for approximately 1 hour before use.They would like to send the unit in for a repair.There was no harm or 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.
Event or Problem Description
The customer reported that the multigas unit displayed "calibration" error while in patient use.
Event or Problem Description
The customer reported that the multigas unit displayed a "calibration" error while in patient use.
Additional Manufacturer Narrative
Details of complaint: the customer reported that the multigas unit displayed a "calibration" error while in patient use.The customer also reported that the etco2 and o2 reading were low.They replaced the dry line water trap 2 days prior to this event, and they allowed the device to warm up for approximately 1 hour before use.They sent the unit in to nihon kohden for repair.No patient harm was reported.Service requested / performed: evaluation / repair: upon nihon kohden repar center (nka rc) evaluation, the reported problem was duplicated.The following malfunctioning part was recognized as needing to be replaced, which could have resolved the issue: #cd-237p-gas unit.Nka rc could not finish the repair of the unit since the necessary parts were unavailable as the unit was sunsetted in 2013.Investigation summary: the cause of the issue was determined to be electronic failure of the gas unit.Per the operator's manual, the possible causes of the unit displaying a "cal error" are issues with the water trap, sampling line, t-piece, or exhaust tube which need to be replaced, if necessary.It could also be caused by incorrect gas being used for calibration.The overall risk score is medium.The reported issue does not require further investigation through capa process since the ag-920ra is a legacy product and sales for the unit ended in 2013.Additional device information: d10 concomitant medical device: the following device(s) were used in conjunction with the multigas unit: bsm: model #: ni, serial #: ni.

• Brand Name: AG-920RA
• Common Device Name: MULTI-GAS UNIT
• MDR Report Key: 9419824
• Report Number: 8030229-2019-00704
• Device Sequence Number: 1724703
• Product Code: CCK
• UDI-Device Identifier: 00841983103162
• UDI-Public: 00841983103162
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K020046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2021
• Report Date (Section F): 12/05/2019

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
• Operator of Device: Health Professional
• Device Model Number: AG-920RA
• Device Catalogue Number: AG-920RA
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2019
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/14/2019
• Device Age: 88 MO
• Event Location: Hospital
• Date Report to Manufacturer: 12/05/2019
• Initial Date Received by Manufacturer: 11/14/2019
• Supplement Date Received by Manufacturer: 10/05/2021
• Initial Report FDA Received Date: 12/05/2019
• Supplement Report FDA Received Date: 10/22/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/19/2012
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BSM
• Date Report Sent to FDA: 12/05/2019