FDA Adverse Event
Injury
Summary report: N
BABYFLOW
MDR report key: 1203014
·
Received October 21, 2008
Report
- Report Number
- 9611500-2008-00034
- Event Type
- Injury
- Date Received
- October 21, 2008
- Date of Event
- September 13, 2008
- Report Date
- October 7, 2008
- Manufacturer
- DRAEGER MEDICAL AG & CO. KG
- Product Code
- NHJ
- PMA / PMN Number
- K903089
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PRONGS WERE REQUESTED FOR INVESTIGATION, BUT NOT YET RECEIVED. INVESTIGATION RESULTS WILL BE REPORTED IN A FOLLOW UP REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT: "BABY, WAS INSTALLED IN THE NASAL-FLOW CPAP SYSTEM. PRIOR TO SUCTIONING BABY'S NARES, CPAP TUBE WAS REMOVED, BRUISING OF THE SEPTUM WAS NOTED AS WELL AS SOME BLOODY DISCHARGE, AND REDNESS AROUND THE NARES. IMMEDIATE CONSEQUENCES TO THE PATIENT: PHYSICAL - REDNESS WITH SKIN BREAKDOWN AND SMALL AMOUNT OF BLEEDING. SEPTUM OF BABY FELL OFF."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BABYFLOW | NEONATAL NASAL FLOW CPAP SYSTEM | NHJ | DRAEGER MEDICAL AG & CO. KG | NA | 8004 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 14 DA | Required Intervention |