FDA Adverse Event
Malfunction
Summary report: N
3002 SECURE II
MDR report key: 2182018
·
Received June 22, 2011
Report
- Report Number
- 1831750-2011-06300
- Event Type
- Malfunction
- Date Received
- June 22, 2011
- Date of Event
- May 27, 2011
- Report Date
- May 27, 2011
- Manufacturer
- STRYKER MEDICAL
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
RESULT: CRACKED SIDERAIL PANELS. DAMAGED POWER CORD. MISSING WARNING LABEL. FAULTY SCALE DISPLAY. DAMAGED MOTION INTERRUPT PAN.
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THE SIDERAIL OUTER AND INNER PANELS HAD STRUCTURAL CRACKS WITH NO SHARP EDGES EXPOSED, BUT POSSIBLE FLUID INGRESS; THE POWER CORD WAS DAMAGED; THERE WAS MISSING A WARNING LABEL; THE SCALE DISPLAY WAS DIM AND DIFFICULT TO READ, AND THE MOTION INTERRUPT PAN WAS DAMAGED. NO PT INVOLVEMENT OR ADVERSE CONSEQUENCES WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 3002 SECURE II | A/C POWERED HOSPITAL BED | FNL | STRYKER MEDICAL | 3002 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |