MAUDE Adverse Event Report: MERCURY MERCURY; AMBU BAG CPR-2

Model Number 13035004

Device Problem Kinked (1339)

Patient Problem No Code Available (3191)

Event Date 10/07/2016

Event Type  malfunction  

Event Description

Ambu bag tubing kinked when it comes from manufacturer.Tubing is delivered coiled and wrapped with band and delivered in plastic bag.Permanent kink is caused as a result of the tubing be packaged bont.Experienced difficult bagging patient due to kink in tubing.

• Brand Name: MERCURY
• Type of Device: AMBU BAG CPR-2
• Manufacturer (Section D): MERCURY
• MDR Report Key: 6033543
• MDR Text Key: 57789890
• Report Number: MW5065438
• Device Sequence Number: 1
• Product Code: BTM
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 13035004
• Is the Reporter a Health Professional?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 30 YR