FDA Adverse Event
Injury
Summary report: N
AIRLIFE PEDIATRIC MANUAL RESUSCITATOR, OXYGEN RESERVOIR BAG, PEDIATRIC MASK, PR
MDR report key: 9777329
·
Received March 2, 2020
Report
- Report Number
- 8030673-2020-00076
- Event Type
- Injury
- Date Received
- March 2, 2020
- Date of Event
- February 4, 2020
- Report Date
- February 4, 2020
- Manufacturer
- CAREFUSION 2200, INC.
- Product Code
- OFP
- UDI-DI
- 10190752114326
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
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.
Description of Event or Problem · 1
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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 239852 | AIRLIFE PEDIATRIC MANUAL RESUSCITATOR, OXYGEN RESERVOIR BAG, PEDIATRIC MASK, PR | ANESTHESIA BREATHING CIRCUIT KIT (ADULT & PEDIATRIC) | OFP | CAREFUSION 2200, INC. | AIRLIFE PEDIATRIC MANUAL RESUSCITATOR, OXYGEN RESERVOIR BAG, PEDIATRIC MASK, PR | 10190752114326 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 11 YR | Required Intervention |