MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL LTD PORTEX; VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)

Model Number 8503

Device Problem No Flow (2991)

Patient Problem Insufficient Information (4580)

Event Date 08/04/2021

Event Type  malfunction  

Event Description

Narrative from staff: as patient was leaving the operating room it was found that o2 was not flowing through the ambu bag to the patient.Crna asked for a new ambu bag and the anesthesiologist got a new one.Patient transported.

• Brand Name: PORTEX
• Type of Device: VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL LTD; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 12352830
• MDR Text Key: 267715453
• Report Number: 12352830
• Device Sequence Number: 1
• Product Code: BTM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 08/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8503
• Device Catalogue Number: 8503
• Device Lot Number: 191212
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/10/2021
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 08/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 21900 DA
• Patient Weight: 120