FDA Adverse Event
Malfunction
Summary report: N
SECURE ACUTE CARE BED
MDR report key: 2073059
·
Received April 21, 2011
Report
- Report Number
- 1831750-2011-03855
- Event Type
- Malfunction
- Date Received
- April 21, 2011
- Date of Event
- March 28, 2011
- Report Date
- March 28, 2011
- Manufacturer
- STRYKER MEDICAL
- Product Code
- INK
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THE UNIT HAD NO AUDIBLE ALARM. IT IS UNK IF THERE WAS PT INVOLVEMENT OR IF THERE ARE ADVERSE CONSEQUENCES TO REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SECURE ACUTE CARE BED | A/C POWERED HOSPITAL BED | INK | STRYKER MEDICAL | 3000 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |