FDA Adverse Event
Malfunction
Summary report: N
SECURE II MED/SURG BED
MDR report key: 2140855
·
Received May 31, 2011
Report
- Report Number
- 1831750-2011-05325
- Event Type
- Malfunction
- Date Received
- May 31, 2011
- Date of Event
- May 3, 2011
- Report Date
- May 3, 2011
- Manufacturer
- STRYKER MEDICAL
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
RESULT: DAMAGED FOOTBOARD MODULE.
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THE HEAD LEFT SIDERAIL PANEL WAS CRACKED AND THERE WAS FLUID INTRUSION. IT WAS FURTHER REPORTED THERE WAS A DAMAGED FOOTBOARD MODULE AND TWO WARNING LABELS REQUIRED REPLACEMENT. NO PATIENT INVOLVEMENT OR ADVERSE CONSEQUENCES ARE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SECURE II MED/SURG BED | A/C POWERED HOSPITAL BED | FNL | STRYKER MEDICAL | 3002 EX | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |