FDA Adverse Event
Malfunction
Summary report: N
IN TOUCH ZX
MDR report key: 2010219
·
Received March 1, 2011
Report
- Report Number
- 1831750-2011-02030
- Event Type
- Malfunction
- Date Received
- March 1, 2011
- Date of Event
- December 14, 2010
- Report Date
- December 14, 2010
- Manufacturer
- STRYKER MEDICAL
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
RESULT: FAULTY PLUNGER ON PT RIGHT SIDE RAIL LIMIT SWITCH.
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THE PT RIGHT HEADSIDE RAIL SWITCH IS NOT ENGAGING THE AUDIBLE ALARM TO GO OFF WHEN THE RAIL IS LOWERED. NO PT INVOLVEMENT OR ADVERSE CONSEQUENCES ARE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | IN TOUCH ZX | A/C HOSPITAL BED | FNL | STRYKER MEDICAL | 2140 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |