MAUDE Adverse Event Report: PORTEX; VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)

Lot Number UNKNOWN

Device Problem Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/20/2020

Event Type  malfunction  

Event Description

Information was received indicating that the portex manual resuscitation bag doesn't reliably provide breaths.Sometimes upon squeezing the bag it skips an inflation every 2-4 breaths.There was no patient injury.

Manufacturer Narrative

This supplemental report is being filed to include additional information patient involved, device worked well enough that no intervention or change in ventilation was needed.

• Brand Name: PORTEX
• Type of Device: VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)
• MDR Report Key: 10877016
• MDR Text Key: 217437811
• Report Number: 3012307300-2020-11639
• Device Sequence Number: 1
• Product Code: BTM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 12/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 11/06/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/30/2020
• 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: Unknown
• Patient Sequence Number: 1