| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | BIODEX RTM 600 TREADMILL | TREADMILL | BIODEX MEDICAL SYSTEMS, INC. | BXB | 950-420 | 950-420 | N |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2011-01-05 | 0 | 1. R |
Patient 1
AN ELDERLY WOMAN PATIENT WAS PLACED ON THE TREADMILL FOR REHAB. THE PHYSICAL THERAPIST AIDE HAD ADJUSTED THE UNIT SPEED OF 2.5 MPH. AS THE AIDE TURNED AWAY AFTER CONFIRMING NORMAL FUNCTION, LESS THAN A MINUTE LATER, THE TREADMILL WAS OPERATING AT A SPEED OF 7.5 MPH RESULTING IN THE PATIENT FALLING CAUSING INJURIES TO BOTH THE WOMEN'S SHOULDERS.
Patient 1
USER HAS A (B)(4) TREADMILL THAT HAS A NEW DISPLAY AND MOTOR CONTROL. USER WAS NOT USING THE SAFETY LANYARD THAT ATTACHES TO THE PATIENT AND WHEN PULLED SHUTS OFF THE TREADMILL. THEY DID NOT PRESS THE EMERGENCY STOP BUTTON THAT ALSO SHUTS OFF THE TREADMILL. THE SITE TOLD BIODEX THAT THE TREADMILL INCREASED IN SPEED BY ITSELF. IF PATIENT PRESSED THE SPEED INCREASE BUTTON THE TREADMILL SPEEDS UP. WE TESTED ANOTHER SIMILAR TREADMILL AND IT DOES NOT SPEED UP BY ITSELF. THE NEW TREADMILLS WERE TESTED AT BIODEX BEFORE SENDING TO CUSTOMERS. BOTH THE SAFETIES WORK ON THE TREADMILL WE HAVE IN HOUSE. WE ARE WAITING THE RETURN OF THE TREADMILL FROM THE CUSTOMER TO FURTHER ANALYZE THE TREADMILL. THE PATIENT FELL WHEN THE THERAPIST ATTEMPTED TO REMOVE THE PATIENT FROM THE TREADMILL WITHOUT STOPPING IT. THEY DID NOT PRESS THE EMERGENCY STOP OR PULL THE SAFETY LANYARD TO STOP THE TREADMILL BEFORE TRYING TO TAKE THE PATIENT OFF THE MOVING TREADMILL.