MAUDE Adverse Event Report: CAREFUSION AIRLIFE MANUAL RESUSCITATOR II

Catalog Number 2K7012

Device Problem Product Quality Problem (1506)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/17/2017

Event Type  Injury  

Event Description

Unsafe design discovered in airlife manual resuscitator bvm device.It is possible to interchange the facemask portion of the bag into the exhalation filter opening which creates a situation where you are not ventilating a pt at all.

• Brand Name: AIRLIFE MANUAL RESUSCITATOR II
• Type of Device: AIRLIFE MANUAL RESUSCITATOR II
• Manufacturer (Section D): CAREFUSION; san diego CA
• MDR Report Key: 6352625
• MDR Text Key: 68245676
• Report Number: MW5068041
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 02/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2K7012
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/22/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention