MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-11-15 for RTM 600 TREADMILL 950-280 manufactured by Biodex Medical Systems, Inc..
[5049903]
Patient fell off treadmill and dislocated her shoulder.
Patient Sequence No: 1, Text Type: D, B5
[12538780]
Biodex was notified (b)(4) 2014 about the problem. We were told the patient was instructed how to use the treadmill and then was not supervised. With pressing the speed button continuously the mill sped up too fast and patient fell off. They did not use the emergency stop button, stop button on the display or the safety lanyard. All of which will disable unit. Biodex is waiting to analyze the unit. Response to 4h-3: biodex medical systems is waiting to hear from the customer so we can go in and evaluate the system, determine the cause and make repairs, if necessary.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2431314-2014-00001 |
| MDR Report Key | 4261723 |
| Report Source | 05,06 |
| Date Received | 2014-11-15 |
| Date of Report | 2014-10-28 |
| Date of Event | 2014-06-16 |
| Date Mfgr Received | 2014-10-23 |
| Device Manufacturer Date | 2008-02-01 |
| Date Added to Maude | 2014-11-20 |
| 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 | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | CLYDE SCHLEIN, VP |
| Manufacturer Street | 20 RAMSAY RD. |
| Manufacturer City | SHIRLEY NY 119674704 |
| Manufacturer Country | US |
| Manufacturer Postal | 119674704 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RTM 600 TREADMILL |
| Generic Name | TREADMILL |
| Product Code | IOL |
| Date Received | 2014-11-15 |
| Model Number | 950-280 |
| Catalog Number | 950-280 |
| 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 | 2014-11-15 |