MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-09-25 for ANTI GRAVITY TREADMILL M320 * manufactured by Alterg Service.
[15265432]
The patient was assisted on to the treadmill. The harness system was elevated and secured. Upon attempting to calibrate the system, there was no response from the machine. In an attempt to reset and retry, we disconnected and tried to lower the harness system, however it would not descend fully to the floor level. Assistance was obtained from other therapists at the clinic and the device was not able to be lowered. After problem solving the safest way to exit the machine, the patient was assisted onto a step and over the harness railing with the assistance of five therapists to ensure safety. The patient was safely assisted out of the machine/treadmill without incident or complaint. The patient's spouse was present throughout. The patient was able to resume therapy without incident, further pain, and other complaints on that day or on subsequent treatments. Per mfr's response to the hospital, the cock pit latch broke. The treadmill needed a system upgrade which included replacement of the latch.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3439899 |
| MDR Report Key | 3439899 |
| Date Received | 2013-09-25 |
| Date of Report | 2013-09-25 |
| Date of Event | 2013-07-03 |
| Report Date | 2013-09-25 |
| Date Reported to FDA | 2013-09-25 |
| Date Reported to Mfgr | 2013-10-31 |
| Date Added to Maude | 2013-10-31 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ANTI GRAVITY TREADMILL |
| Generic Name | EXERCISER, POWERED |
| Product Code | BXB |
| Date Received | 2013-09-25 |
| Model Number | M320 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | 2 YR |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALTERG SERVICE |
| Manufacturer Address | 48438 MILMONT DRIVE FREMONT CA 94538 US 94538 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-09-25 |