FDA Adverse Event
Malfunction
Summary report: N
EPIC II CRITICAL CARE BED
MDR report key: 1840424
·
Received September 10, 2010
Report
- Report Number
- 1831750-2010-02381
- Event Type
- Malfunction
- Date Received
- September 10, 2010
- Date of Event
- August 24, 2010
- Report Date
- August 24, 2010
- Manufacturer
- STRYKER CORP. MEDICAL DIV.
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
MAIN MODULE ASSEMBLY AND THE FOOTBOARD WAS CRACKED.
Description of Event or Problem · 1
IT WAS REPORTED IN A SERVICE REPORT THAT THE FOOTBOARD WAS CRACKED AND THE BED EXIT ALARM WAS NOT FUNCTIONAL. NO ADVERSE CONSEQUENCES WERE ALLEGED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EPIC II CRITICAL CARE BED | A/C POWERED HOSPITAL BED | FNL | STRYKER CORP. MEDICAL DIV. | 2030 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |