MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. HIGH FLOW INSUFFLATION UNIT

Model Number UHI-3

Device Problem Device Sensing Problem (2917)

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

Event Type  malfunction  

Manufacturer Narrative

Event date for this event is (b)(6) 2021.This device was returned for inspection without any specified malfunction.During estimation it was observed that the was power on without carbondioxide (co2) gas inside, the two green light emitting diode (led) lights of the bar graph for measuring pressure lit up at the same time.This is caused by faulty main board.All other functionality is working.In addition, the top cover and front panel have minor scratches, and the color of the front panel is minor faded.The bottom chassis is minor rusty.They are okay to reuse.Evaluation is ongoing.Supplemental report(s) will be submitted when any relevant new information is available.

Event Description

This device was returned for inspection without any specified malfunction.During estimation it was observed that the device was powered on without carbondioxide (co2) gas inside, and the two green light emitting diode (led) lights of the bar graph for measuring pressure lit up at the same time.This is caused by faulty main board.There is no harm reported to any patient.

Manufacturer Narrative

There is more information on the device evaluation.This supplemental report is being submitted to provide this information.The device history record review confirmed that device has no manufacturing abnormalities, special hires, or variations.The root cause of the main board failure that led to the issue of two separate light emitting diode (led) lights on the pressure display bar graph being lit at the same time cannot be conclusively determined.However, since it has been more than 15 years since it was manufactured, it is considered to be a failure due to aging deterioration.

• Brand Name: HIGH FLOW INSUFFLATION UNIT
• Type of Device: HIGH FLOW INSUFFLATION UNIT
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 12050418
• MDR Text Key: 257767152
• Report Number: 8010047-2021-07889
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• PMA/PMN Number: K014166
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 09/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: UHI-3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1