FDA Adverse Event
Injury
Summary report: N
OOK SNOW
MDR report key: 7067892
·
Received November 29, 2017
Report
- Report Number
- 3009591865-2017-00003
- Event Type
- Injury
- Date Received
- November 29, 2017
- Report Date
- November 27, 2017
- Manufacturer
- UMANO MEDICAL INC
- Product Code
- FNL
- UDI-DI
- 00670482000067
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- SERVICE PERSONNEL
Narratives
Description of Event or Problem · 1
TECHNICAL SERVICE REPRESENTATIVE OF THE MANUFACTURER, WHILE AT CUSTOMER SITE FOR VERIFICATION OF DETECTION SYSTEM SENSITIVITY AND SYMMETRY, WAS REPORTED A PATIENT FALL. THE MAINTENANCE MANAGER ALLEGED THAT A PATIENT FELT AFTER EXITING THE BED WHILE THE BED DETECTION SYSTEM WAS ARMED. IT WAS FURTHER REPORTED BY HEALTHCARE PROFESSIONAL THAT BED EXIT SYSTEM WAS IN ALARM WHEN THEY ARRIVED, THAT THE COMMUNICATION RELAYS TAKES BETWEEN 15 TO 22 SECONDS AND THAT THERE WERE NO INJURY ASSOCIATED WITH THE PATIENT FALL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 847742 | OOK SNOW | MEDICAL BED | FNL | UMANO MEDICAL INC | OOK SNOW | 00670482000067 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |