FDA Adverse Event
Death
Summary report: N
INFINITY ACS WORKSTATION NC
MDR report key: 4133291
·
Received August 28, 2014
Report
- Report Number
- 9611500-2014-00048
- Event Type
- Death
- Date Received
- August 28, 2014
- Date of Event
- August 7, 2014
- Report Date
- August 21, 2014
- Manufacturer
- DRAEGER MEDICAL GMBH
- Product Code
- CBK
- PMA / PMN Number
- K093632
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GR
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
THE CONCERNED VENTILATOR WAS REQUESTED FOR INVESTIGATION ON MANUFACTURER SITE, BUT NOT YET RECEIVED. THE INVESTIGATION RESULTS WILL BE REPORTED IN THE FOLLOW UP REPORT.
Description of Event or Problem · 1
THE NEONATAL VENTILATOR CREATED AN ERR FIO2 AND STOPPED TO DISTRIBUTED O2 TO THE NEONATE. DOCTORS TRANSFERRED THE NEONATE TO A DIFFERENT VENTILATOR (NON DRAEGER DEVICE) AND AFTER SOME HOURS THE NEONATE DIED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 525839 | INFINITY ACS WORKSTATION NC | VENTILATOR, NEONATAL | CBK | DRAEGER MEDICAL GMBH | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |