FDA Adverse Event
Malfunction
Summary report: N
MONDIAL ST64 OPT1
MDR report key: 2527683
·
Received March 20, 2012
Report
- Report Number
- 1523574-2012-00001
- Event Type
- Malfunction
- Date Received
- March 20, 2012
- Date of Event
- January 27, 2012
- Report Date
- February 19, 2012
- Manufacturer
- FERNO-WASHINGTON, INC.
- Product Code
- FPO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE TRANSPORTER HAD NOT BEEN PLACED IN SERVICE. THIS INCIDENT OCCURRED WHILE TRAINING AN EMT ON NEW PRODUCT.
Description of Event or Problem · 1
THE LOAD HEIGHT REQUIREMENTS OF THE TRANSPORTER WAS NOT COMPATIBLE TO THE HEIGHT OF THE AMBULANCE FLOOR. AN EMT ATTEMPTED TO LOAD THE TRANSPORTER AND STRAINED THEIR BACK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MONDIAL ST64 OPT1 | MONDIAL | FPO | FERNO-WASHINGTON, INC. | ST64 OPT1 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Required Intervention |