MAUDE Adverse Event Report: WESTERN/SCOTT FETZER CO. OXYTOTE DTE; DIGITAL OXYGEN REGULATOR

Model Number MNDR-600

Device Problem Device Emits Odor (1425)

Patient Problem Cough (4457)

Event Date 01/04/2022

Event Type  malfunction  

Manufacturer Narrative

Initial 30-day report filing was delayed due to the enrollment process.

Event Description

As hospital personnel administered oxygen to the patient, the patient complained of an acrid smell which prompted the patient to start coughing.The unit was shut off and removed from the room.The patient's coughing immediately subsided.No injury occurred, and treatment associated with this event was not necessary.

• Brand Name: OXYTOTE DTE
• Type of Device: DIGITAL OXYGEN REGULATOR
• Manufacturer (Section D): WESTERN/SCOTT FETZER CO.; 875 bassett road; westlake OH 44145
• Manufacturer (Section G): WESTERN/SCOTT FETZER CO.; 875 bassett road; westlake OH 44145
• Manufacturer Contact: lindyn humenik ; 875 bassett road; westlake, OH 44145 ; 4408726471
• MDR Report Key: 13694056
• MDR Text Key: 289332701
• Report Number: 1526809-2022-00001
• Device Sequence Number: 1
• Product Code: CAN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NONE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 01/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MNDR-600
• Device Catalogue Number: MNDR-600
• Device Lot Number: NONE
• Date Manufacturer Received: 01/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2021
• 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