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

Device Problem Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/04/2020

Event Type  Injury  

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 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
• Type of Device: ANESTHESIA BREATHING CIRCUIT KIT (ADULT & PEDIATRIC)
• Manufacturer (Section D): CAREFUSION 2200, INC.; 75 n fairway dr; vernon hills IL 60061
• Manufacturer (Section G): PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V.; cerrada vía de la producción; 85 parque undustrial mex iii; mexicali, 21397 ; MX 21397
• Manufacturer Contact: mindy faber ; 26125 n. riverwoods blvd.; mettawa, IL 60045
• MDR Report Key: 9777329
• MDR Text Key: 188824173
• Report Number: 8030673-2020-00076
• Device Sequence Number: 1
• Product Code: OFP
• UDI-Device Identifier: 10190752114326
• UDI-Public: (01)10190752114326
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/04/2020
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 11 YR