FDA Adverse Event
Injury
Summary report: N
AIRLIFE INFANT NCPAP GENERATOR KIT
MDR report key: 1604772
·
Received October 21, 2009
Report
- Report Number
- 1604772
- Event Type
- Injury
- Date Received
- October 21, 2009
- Date of Event
- June 26, 2009
- Report Date
- September 17, 2009
- Manufacturer
- CARDINAL HEALTH
- Product Code
- BZD
- Adverse Event
- Yes
- Report Source
- User Facility report
- Reporter Location
- CA, US
- Reporter Occupation
- NURSE
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AIRLIFE INFANT NCPAP GENERATOR KIT | INTERFACE FOR NCPAP | BZD | CARDINAL HEALTH | * | Y09C0642 | |
| 2 | AIRLIFE INFANT NASAL SILICONE MASK | NCPAP NASAL SILICONE MASK | BZD | CARDINAL HEALTH | * | Y09C0286 | |
| 3 | DRAGER BABY FLOW DISPOSABLE | INTERFACE FOR NCPAP | BZD | DRAGER MEDICAL | * | 005447 | |
| 4 | BABY FLOW PRONG SMALL | NASAL PRONGS FOR NCPAP | BZD | DRAGER MEDICAL | * | 8006 | |
| 5 | BABY FLOW MASK SMALL | MASK FOR NCPAP | BZD | DRAGER MEDICAL | * | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 17 DAY | Required Intervention |