MAUDE Adverse Event Report: CAREFUSION 2200, INC. AIRLIFE PEDIATRIC MANUAL RESUSCITATOR, OXYGEN RESERVOIR BAG, PEDIATRIC MASK, PR; ANESTHESIA BREATHING CIRCUIT KIT (ADULT & PEDIATRIC)

Model Number	AIRLIFE PEDIATRIC MANUAL RESUSCITATOR, OXYGEN RESERVOIR BAG, PEDIATRIC MASK, PR
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/04/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Only the photo has been evaluated.No sample returned.The customer stated it is a device malfunction, where the device did not do what it was supposed to do.Vyaire file identification: any additional information received from the customer will be included in a follow-up report.
Event or Problem Description
The customer reported that the airlife pediatric manual resuscitator experienced a pediatric bag failure during patient use.The customer confirmed that the problem was quickly identified and there was no patient harm associated with this reported event.As an intervention, they got another pediatric bag and it worked just fine.

• Brand Name: AIRLIFE PEDIATRIC MANUAL RESUSCITATOR, OXYGEN RESERVOIR BAG, PEDIATRIC MASK, PR
• Common Device Name: ANESTHESIA BREATHING CIRCUIT KIT (ADULT & PEDIATRIC)
• Manufacturer (Section D): CAREFUSION 2200, INC.; 75 n fairway dr; vernon hills IL 60061
• MDR Report Key: 9777329
• Report Number: 8030673-2020-00076
• Device Sequence Number: 16501792
• Product Code: OFP
• UDI-Device Identifier: 10190752114326
• UDI-Public: (01)10190752114326
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: AIRLIFE PEDIATRIC MANUAL RESUSCITATOR, OXYGEN RESERVOIR BAG, PEDIATRIC MASK, PR
• Device Catalogue Number: 2K8020
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/04/2020
• Initial Report FDA Received Date: 03/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 11 YR