FDA Adverse Event
Malfunction
Summary report: N
OUTLOOK 200 WITH PIGGYBACK REMINDER
MDR report key: 1040369
·
Received May 6, 2008
Report
- Report Number
- 1641965-2008-00027
- Event Type
- Malfunction
- Date Received
- May 6, 2008
- Date of Event
- April 8, 2008
- Report Date
- April 8, 2008
- Manufacturer
- B. BRAUN MEDICAL, INC.
- Product Code
- FRN
- PMA / PMN Number
- K011975
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
DEVICE EVALUATION RESULTS WILL BE SUBMITTED WHEN EVALUATION IS COMPLETE.
Description of Event or Problem · 1
DEVICE REPORTEDLY FAILED DRIP TESTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OUTLOOK 200 WITH PIGGYBACK REMINDER | INFUSION PUMP | FRN | B. BRAUN MEDICAL, INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |