FDA Adverse Event
Malfunction
Summary report: N
EPIC II CRITICAL CARE BED
MDR report key: 2972295
·
Received February 21, 2013
Report
- Report Number
- 0001831750-2013-01415
- Event Type
- Malfunction
- Date Received
- February 21, 2013
- Date of Event
- January 26, 2013
- Report Date
- January 28, 2013
- Manufacturer
- STRYKER MEDICAL-KALAMAZOO
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
RESULT - FOWLER MOTOR. CONCLUSION - CUSTOMER WILL DO OWN REPAIRS. WHEN SERVICE TECH ARRIVED TO INSPECT THE BED, HE FOUND THAT THE CUSTOMER HAD ALREADY DISASSEMBLED THE FOWLER AND THE FOWLER MOTOR WAS MISSING. HE ALSO NOTICED THAT THE CPU HAD MALFUNCTIONED.
Description of Event or Problem · 1
IT WAS REPORTED BY THE CUSTOMER THAT THE FOWLER WAS STUCK IN AN ELEVATED POSITION. UPON EVALUATION BY THE SERVICE TECH, IT WAS FOUND THAT THE CPU HAD ALSO MALFUNCTIONED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 75570 | EPIC II CRITICAL CARE BED | BED, AC-POWERED ADJUSTABLE HOSPITAL | FNL | STRYKER MEDICAL-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |