MAUDE Adverse Event Report: INSPIRED O2FLO; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPO

Catalog Number 51006141

Device Problem Melted (1385)

Patient Problem No Information (3190)

Event Date 09/08/2020

Event Type  malfunction  

Event Description

It was reported that the connection cable at the heated patient circuit hub of a smiths medical o2 therapy device has been burnt.No patient injury.

Manufacturer Narrative

Smiths medical does not have complaint or reporting responsibility for the product item related to this complaint.(b)(4) will be closed as a non-complaint file.

Event Description

Smiths medical does not have complaint or reporting responsibility for the product item related to this complaint.(b)(4) will be closed as a non-complaint file.

• Brand Name: INSPIRED O2FLO
• Type of Device: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPO
• MDR Report Key: 10624926
• MDR Text Key: 210594778
• Report Number: 3012307300-2020-09893
• Device Sequence Number: 1
• Product Code: MNT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 01/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 51006141
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/11/2021
• 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: N
• Patient Sequence Number: 1