MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. AIRWAY MOBILESCOPE

Model Number	MAF-GM
Health Effect - Clinical Codes	Arrhythmia (1721); Cardiac Arrest (1762); Hypoxia (1918)
Type of Reportable Event	Serious Injury
Event or Problem Description
It is reported in the literature article titled "management of patients with predicted difficult airways in an academic emergency department ", two of seven patients from the awake group had airway intubation performed using olympus maf-gm.Five patients from this group experienced adverse events (hypoxia-2, dysrhythmia-2, and peri-intubation arrest-1).There is no specific information available to clarify which (if any) of the five patients experiencing an adverse event were intubated using the maf-gm.It is reported that all patients in this study were predicted to have difficult airways to intubate.It is also reported that no patient in this study required surgical airway intervention.This report is being submitted to report the potential that an olympus device could have caused or contributed to an adverse event in either of the two patients that were intubated using the maf-gm.There is no report that the maf-gm malfunctioned in any way.

• Brand Name: AIRWAY MOBILESCOPE
• Common Device Name: AIRWAY MOBILESCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 11424113
• Report Number: 2951238-2021-00298
• Device Sequence Number: 4040581
• Product Code: EOQ
• UDI-Device Identifier: 04953170340369
• UDI-Public: 04953170340369
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/05/2021
• Report Date (Section F): 02/08/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: MAF-GM
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/08/2021
• Event Location: Hospital
• Date Report to Manufacturer: 02/08/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2021
• Initial Report FDA Received Date: 03/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other