FDA Adverse Event
Malfunction
Summary report: N
STAIR PRO - MODEL 6252
MDR report key: 2981383
·
Received February 27, 2013
Report
- Report Number
- 0001831750-2013-01565
- Event Type
- Malfunction
- Date Received
- February 27, 2013
- Date of Event
- February 13, 2013
- Report Date
- February 18, 2013
- Manufacturer
- STRYKER MEDICAL-KALAMAZOO
- Product Code
- FPP
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PL
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CORRECTED THE SERIAL NUMBER THAT WAS ORIGINALLY REPORTED TO (B)(4). DEVICE EVALUATED.
Description of Event or Problem · 1
IT WAS REPORTED VIA SALES REPRESENTATIVE REPORT THAT THE STAIR CHAIR DOES NOT ENGAGE DOWN THE STAIRS PROPERLY. FURTHERMORE, NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.
Description of Event or Problem · 1
IT WAS REPORTED VIA SALES REPRESENTATIVE REPORT THAT THE STAIR CHAIR DOES NOT ENGAGE DOWN THE STAIRS PROPERLY. FURTHERMORE, NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 85672 | STAIR PRO - MODEL 6252 | STRETCHER, HAND-CARRIED | FPP | STRYKER MEDICAL-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |