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

Model Number UHI-4

Device Problems Erratic or Intermittent Display (1182); Improper Flow or Infusion (2954)

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

Event Date 06/11/2021

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to olympus medical systems corp.(omsc) but was returned to (b)(4) for evaluation.(b)(4) inspected the device and confirmed the following: the device has not been repaired in the past year.-he phenomenon reported by the user could not be reproduced.The phenomenon of inability to feed air was not reproduced during the inspection of the device, so the exact cause could not be conclusively determined.However, since the main board had failed, it may have been caused by the failure of the main board.Also, the phenomenon that the front panel display turned black was caused by a failure of the main board.The exact cause of the main board failure could not be conclusively determined, because the device has not been returned to omsc.However, based on the phenomenon, it may have been caused by the detection of an anomaly in the internal circuitry.The abnormality of the internal circuit may have been caused by the failure of the pressure sensor mounted on the main board.In addition, the failure of the pressure sensor mounted on the main board may have been caused by any of the following process errors; oxygen entered the device and the electrode of the pressure sensor was oxidized and corroded.The wiring inside the pressure sensor was peeled off due to oxidative corrosion.Foreign material (epoxy) had adhered due to a mounting error of the parts, and the wires inside the pressure sensor were peeled off due to the foreign material adhering.The instruction manual provides that the cause of the abnormality that all leds are off is that an error has been detected in the internal circuit of the device.Device history record (dhr) review indicates that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.If additional information becomes available, this report will be supplemented.

Event Description

The user facility returned the device to olympus (b)(4) due to malfunction of air supply during preparation for use.There was no report of patient injury associated with the event as the user replaced the device to another device and completed the intended procedure.(b)(4) then inspected the device and found that the front panel display occasionally turned black due to the cr board failure.In addition, the device sometimes could not supply air due to the cr board failure, but the device became normal after rebooting.

• 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: 12148521
• MDR Text Key: 280507273
• Report Number: 8010047-2021-08699
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• PMA/PMN Number: K122180
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial
• Report Date: 07/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: UHI-4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1