FDA Adverse Event
Malfunction
Summary report: N
SEMI ELECTRIC FOOT SPRING 9153638202
MDR report key: 4821842
·
Received June 5, 2015
Report
- Report Number
- 1031452-2015-14196
- Event Type
- Malfunction
- Date Received
- June 5, 2015
- Report Date
- May 18, 2015
- Manufacturer
- INVACARE FLORIDA OPERATIONS
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
FOLLOW UP TO BE SENT IF ADDITIONAL INFORMATION IS RECEIVED
Description of Event or Problem · 1
THE DEALER STATES THAT ONE OF THE CROSSBARS BROKE AT A WELD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 366050 | SEMI ELECTRIC FOOT SPRING 9153638202 | BED, AC-POWERED ADJUSTABLE HOSPITAL | FNL | INVACARE FLORIDA OPERATIONS | 5310IVC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |