FDA Adverse Event
Other
Summary report: N
RNT SYSTEMS
MDR report key: 572471
·
Received February 11, 2005
Report
- Report Number
- 1650927-2005-00001
- Event Type
- Other
- Date Received
- February 11, 2005
- Date of Event
- January 17, 2005
- Report Date
- February 10, 2005
- Manufacturer
- NURSE ASSIST, INC.
- Product Code
- KMI
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
RN PLUS BED ALARM SET UP INTACT ON PT'S BED. WAS FUNCTIONING PROPERLY EARLIER IN THE EVENING. PT CAME OUT OF BED. FOUND SITTING ON FLOOR BESIDE BED. BED ALARM DID NOT GO OFF TO WARN STAFF THAT PT WAS GETTING UP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RNT SYSTEMS | BED ALARM | KMI | NURSE ASSIST, INC. | BPS-10RF | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 84 YR | Other |