FDA Adverse Event
Other
Summary report: N
EASY CARE ELECTRIC BED
MDR report key: 3125311
·
Received May 16, 2013
Report
- Report Number
- 3009402404-2013-00023
- Event Type
- Other
- Date Received
- May 16, 2013
- Date of Event
- April 25, 2013
- Report Date
- May 16, 2013
- Manufacturer
- JOERNS HEALTHCARE
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
IT WAS REPORTED TO THE MFR BY THE USER FACILITY ((B)(6)), PER THE FACILITY, THE HI/LO ACTUATOR PIN CAME OUT CAUSING THE LEG TO DROP, BENDING THE ACTUATOR. THERE WAS A RESIDENT IN THE BED, BUT NO ONE WAS INJURED. CONTACT WAS MADE ON (B)(4) 2013 WITH (B)(6) AT THE FACILITY, WHO STATED THAT I SHOULD CONTACT MAINTENANCE. CONTACT WAS MADE ON (B)(4) 2013 WITH (B)(6), ENVIRONMENTAL, AT THE FACILITY, WHOM STATED THAT SHE WOULD CALL ME BACK. AFTER THE INITIAL CONTACT WITH (B)(6), SEVERAL CALLS WERE MADE TO THE FACILITY ON MULTIPLE OCCASIONS WITH NO FURTHER RESPONSE FROM THE FACILITY. (B)(4) WAS ENTERED INTO OUR SYSTEM. (B)(4) WAS INITIATED IN OUR SYSTEM FOR PRODUCT EVAL. THE PRODUCT HAS NOT BEEN RETURNED TO JOERNS AS OF THE WRITING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 218711 | EASY CARE ELECTRIC BED | PATIENT HOSPITAL BED | FNL | JOERNS HEALTHCARE | ECS7 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |