FDA Adverse Event
Malfunction
Summary report: N
INCUBATOR 8000
MDR report key: 535594
·
Received March 19, 2004
Report
- Report Number
- 9611500-2004-00005
- Event Type
- Malfunction
- Date Received
- March 19, 2004
- Date of Event
- February 19, 2004
- Report Date
- March 19, 2004
- Manufacturer
- DRAGER MEDICAL AG & CO. KGAA
- Product Code
- FMZ
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT AFTER A BREAK DOWN OF MAINS SUPPLY THE DISPLAY OF THE INCUBATOR WAS FREEZED AND THE KEYBOARD COULD NOT BE ACTIVATED, HEATER INACTIVE (NO ALARM). AFTER SWITCHING OFF AND ON, THE DEVICE BEHAVED AS SPECIFIED. THE REPORTED SYMPTOM COULD NOT BE REPRODUCED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INCUBATOR 8000 | NEONATAL INCUBATOR | FMZ | DRAGER MEDICAL AG & CO. KGAA | INCUBATOR 8000 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Required Intervention |