MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-01-05 for BIODEX RTM 600 TREADMILL 950-420 manufactured by Biodex Medical Systems, Inc..
[17070310]
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 Sequence No: 1, Text Type: D, B5
[17232663]
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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2431314-2010-00001 |
| MDR Report Key | 1956248 |
| Report Source | 06 |
| Date Received | 2011-01-05 |
| Date of Report | 2010-12-28 |
| Date of Event | 2010-12-02 |
| Date Mfgr Received | 2010-12-03 |
| Device Manufacturer Date | 2010-03-01 |
| Date Added to Maude | 2011-01-14 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | CLYDE SCHLEIN |
| Manufacturer Street | 20 RAMSAY RD. |
| Manufacturer City | SHIRLEY NY 11967 |
| Manufacturer Country | US |
| Manufacturer Postal | 11967 |
| Manufacturer Phone | 6319249000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIODEX RTM 600 TREADMILL |
| Generic Name | TREADMILL |
| Product Code | BXB |
| Date Received | 2011-01-05 |
| Model Number | 950-420 |
| Catalog Number | 950-420 |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIODEX MEDICAL SYSTEMS, INC. |
| Manufacturer Address | 20 RAMSAY RD. SHIRLEY NY 11967 US 11967 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2011-01-05 |