MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2015-01-26 for ALTERG ANTI-GRAVITY TREADMILL F320 manufactured by Alterg, Inc.
[20012455]
A patient was injured exiting the f320 product after a workout session. According to the director of rehab at the facility, the patient has just ended his session and was having his vitals taken. While exiting the treadmill, the cockpit was unlocked; the patient was not vertically stable and put weight on his heels. This caused the treadmill belt to move forward, causing his feet to slide out from under him. The patient could not stop the momentum, nor could the pt aiding the patient. The patient sat on the rear of the cockpit, which added further weight and momentum to the fall, his legs fell out in front of him, and were pinned under the front of the cockpit. Note the patient had been in the equipment once before. He was considered a minimum-assist patient, and was wearing a gait belt. The pt was to the side of the equipment, and was unable to assist the patient to stand-up vertically once the process began, nor to stop the progress of the belt slippage.
Patient Sequence No: 1, Text Type: D, B5
[20190876]
Alterg inc. Will address the issue by notifying all customers on the importance of ensuring patient stability before entry/exit of alterg equipment to protect patients from following transitions.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007033433-2015-00001 |
| MDR Report Key | 4459680 |
| Report Source | 05 |
| Date Received | 2015-01-26 |
| Date of Report | 2015-01-22 |
| Date of Event | 2015-01-16 |
| Date Mfgr Received | 2015-01-16 |
| Device Manufacturer Date | 2013-09-01 |
| Date Added to Maude | 2015-01-29 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | PARAMJIT BRAR |
| Manufacturer Street | 48438 MILMONT DRIVE |
| Manufacturer City | FREMONT CA 94538 |
| Manufacturer Country | US |
| Manufacturer Postal | 94538 |
| Manufacturer Phone | 5102705900 |
| Single Use | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALTERG ANTI-GRAVITY TREADMILL |
| Generic Name | IOL, TREADMILL POWERED |
| Product Code | IOL |
| Date Received | 2015-01-26 |
| Model Number | F320 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALTERG, INC |
| Manufacturer Address | 48438 MILMONT DRIVE FREMONT CA 94538 US 94538 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-01-26 |