MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. HIGH FLOW INSUFFLATION UNIT

Model Number UHI-4

Device Problems Audible Prompt/Feedback Problem (4020); No Visual Prompts/Feedback (4021)

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

Event Date 02/28/2024

Event Type  malfunction  

Manufacturer Narrative

The device was not returned.Should additional relevant information become available, a supplemental report will be submitted.This report is related to linked patient identifier (b)(6).

Event Description

It was reported to olympus that the insufflation unit had a blank led and caution tone sounded continually.The alarm sound was generated and the front panel was turned off.There were no reports of patient harm.

Manufacturer Narrative

This report is being supplemented to provide additional information, based on the legal manufacturer's final investigation and device evaluation.Additionally, to provide correction to the initial with information inadvertently left out (g2), to provide additional information received through follow up (b5) and to provide an update to fields (d8, d9, h4, and h4).The device was evaluated by olympus.And it was confirmed, that [alarm sound is generated and the front panel is turned off occurred.A review of the device history record found no deviations, that could have caused or contributed to the reported issue.Based on the results of the investigation, it is likely, the phenomenon "alarm sound is generated and the front panel is turned off" occurred, due to mother board failure.However, the root cause of the phenomenon could not be identified.Olympus will continue to monitor field performance for this device.

Event Description

The device malfunction occurred in the middle of an unknown procedure.The device was reset and the procedure continued.A delay of approximately 30 seconds occurred, while the patient was under anesthesia.To reset the device and recycle the power.The procedure was completed using the same device.No error messages were displaced, due to the device malfunction.

• Brand Name: HIGH FLOW INSUFFLATION UNIT
• Type of Device: HIGH FLOW INSUFFLATION UNIT
• Manufacturer (Section D): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer (Section G): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18856669
• MDR Text Key: 337755536
• Report Number: 3002808148-2024-02149
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 04953170324147
• UDI-Public: 04953170324147
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122180
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 03/07/2024

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
• Device Operator: Health Professional
• Device Model Number: UHI-4
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/28/2024
• Initial Date FDA Received: 03/07/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1