FDA Adverse Event
Other
Summary report: N
CARESENSE BSN-020
MDR report key: 513658
·
Received February 20, 2004
Report
- Report Number
- 1650927-2004-00002
- Event Type
- Other
- Date Received
- February 20, 2004
- Date of Event
- November 26, 2003
- Report Date
- January 16, 2004
- Manufacturer
- NURSE ASSIST, INC.
- Product Code
- KMI
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
CUSTOMER CLAIMS THAT PRODUCT DID NOT SIGNAL THE NURSE WHEN THEIR PT EXITED THE BED AND FELL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CARESENSE BSN-020 | BED EXIT SENSOR PAD | KMI | NURSE ASSIST, INC. | BSN-020 | 308059 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Other |