MAUDE Adverse Event Report: CAREFUSION MAPLESON 1 LITER BAG

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/22/2013

Event Type  Injury  

Event Description

A 1 liter non-self inflating mapleson resuscitator came apart while bagging the patient.A back up was available and used without affecting the patient.The patient was brought to the hospital because of asphyxiation/strangulation injury.

• Brand Name: MAPLESON 1 LITER BAG
• Type of Device: MAPLESON 1 LITER BAG
• Manufacturer (Section D): CAREFUSION; vernon hills IL 60061
• MDR Report Key: 3628056
• MDR Text Key: 4179281
• Report Number: MW5034410
• 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: 02/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 5 YR