MAUDE Adverse Event Report: CAREFUSION 2200, INC. CAREFUSION PEDIATRIC RESUSCITATION BAG; PULMONARY RESUSCITATOR, MANUAL, REUSABLE

Device Problem Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/26/2019

Event Type  malfunction  

Event Description

We had a pediatric bag fail on us in the emergency room.Crna's were intubating an (b)(6) male patient.After they tubed the child they could not get chest rise with bagging.The pop off valve seemed to be defective.Rt got them another pediatric bag and it worked just fine.The problem was quickly identified and no harm was done to the patient.The bag was taken out of service.

• Brand Name: CAREFUSION PEDIATRIC RESUSCITATION BAG
• Type of Device: PULMONARY RESUSCITATOR, MANUAL, REUSABLE
• Manufacturer (Section D): CAREFUSION 2200, INC.; 75 north fairway drive; vernon hills IL 60061
• MDR Report Key: 9636279
• MDR Text Key: 176585387
• Report Number: 9636279
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/09/2020
• Event Location: Hospital
• Date Report to Manufacturer: 01/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 4015 DA