FDA Adverse Event
Malfunction
Summary report: N
EPIC II CRITICAL CARE BED
MDR report key: 1942818
·
Received December 10, 2010
Report
- Report Number
- 1831750-2010-04718
- Event Type
- Malfunction
- Date Received
- December 10, 2010
- Date of Event
- November 17, 2010
- Report Date
- November 17, 2010
- Manufacturer
- STRYKER CORP., MEDICAL DIV.
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
RESULT: REPLACED SUSPECTED SIDE RAIL ASSEMBLY.
Description of Event or Problem · 1
IT WAS REPORTED VIA KEVIN THOMAS, FIELD TECH, THAT HE HAD RECEIVED A CALL FROM THE FACILITY WHILE HE WAS ON SITE, REPORTING THAT A PRODUCT WAS GOING INTO TREND WITHOUT PRODUCT BEING TOUCHED. IT WAS REPORTED THE PATIENT FELL OUT OF THE BED. THE PATIENT FOUND ON THE FLOOR BY THE NURSING STAFF. NO ADVERSE CONSEQUENCES OR INJURIES WERE REPORTED.
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 | UNK |