MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION OLG-2800A; CARBON DIOXIDE MONITOR

Model Number	OLG-2800A
Medical Device Problem Code	Inaudible or Unclear Audible Prompt/Feedback (2283)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported that this stand-alone etco2 monitor (olg-2800) alarm sound is very quiet and that they cannot hear it at the nurse's station.The customer turned the alarm volume up to 8; which is the highest setting and still cannot hear the alarm sound outside of the patient's room.The customer asked nihon kohden for other options as this issue does not meet the customer patient safety needs.Nihon kohden provided the customer with an option of a nurse call output that will turn on a light, but this requires installation.Nihon kohden continues to investigate the reported event.Nihon kohden will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
Event or Problem Description
The customer reported that this stand-alone etco2 monitor (olg-2800) alarm sound is very quiet and that they cannot hear it at the nurse's station.No consequence or impact to the patient was reported.
Event or Problem Description
The customer reported that this stand-alone etco2 monitor (olg-2800) alarm sound is very quiet and that they cannot hear it at the nurse's station.No consequence or impact to the patient was reported.
Additional Manufacturer Narrative
Details of complaint: on (b)(6) 2019 customer communicated with nk sales rep brian cassidy of low alarm volume; it could not be heard outside of the room.Service requested: troubleshooting.Service performed: troubleshooting.Investigation result: customer voiced concerned about the alarm volume for olg-2800a at the nurse's station.There was no concern with alarm volume when the clinical is present in the room.This is a user need that is being addressed by other product solutions.Customer wanted to explore other options.Options for this user need are: 1) network device (olg-3800a) or 2) nurse call output.Nk sales rep was informed of these options.Customer currently have 2 olg-2800a installed.Service history for both devices show no other incidents have been reported since (b)(6) 2019.

• Brand Name: OLG-2800A
• Common Device Name: CARBON DIOXIDE MONITOR
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; 1-31-4 nishiochia, shinjuku-ku; attn: shama mooman; tokyo, 161-8 560; JA 161-8560
• MDR Report Key: 8913542
• Report Number: 8030229-2019-00390
• Device Sequence Number: 2000538
• Product Code: CCK
• UDI-Device Identifier: 04931921103814
• UDI-Public: 4931921103814
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K062115
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2019
• Report Date (Section F): 12/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: OLG-2800A
• Device Catalogue Number: OLG-2800A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/13/2019
• Device Age: 42 MO
• Event Location: Hospital
• Date Report to Manufacturer: 12/03/2019
• Initial Date Received by Manufacturer: 06/28/2019
• Supplement Date Received by Manufacturer: 11/13/2019
• Initial Report FDA Received Date: 08/20/2019
• Supplement Report FDA Received Date: 12/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 12/03/2019