FDA Adverse Event
Malfunction
Summary report: N
SECA
MDR report key: 5147785
·
Received October 14, 2015
Report
- Report Number
- 5147785
- Event Type
- Malfunction
- Date Received
- October 14, 2015
- Date of Event
- September 29, 2015
- Report Date
- September 29, 2015
- Manufacturer
- SECA CORP.
- Product Code
- FRW
- Adverse Event
- Yes
- Report Source
- User Facility report
- Reporter Location
- CA, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Description of Event or Problem · 1
THE SCALE IS VERY SENSITIVE TO BEING BALANCE SO IT HAS A LEVEL BUILT IN SO THE USER OR SERVICE PERSON KNOWS IF IT IS BALANCED. THE LEVEL IS LOCATED ON THE BACK OF THE SCALE PARTIALLY UNDER THE BASE SO IF THIS SCALE IS NEAR A WALL (WHICH MOST SCALES ARE) IT IS IMPOSSIBLE TO SEE THE LEVEL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 679344 | SECA | SCALE | FRW | SECA CORP. | 644 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |