MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-08 for ANTI-GRAVITY TREADMILL M320 manufactured by Alterg, Inc..
[77534952]
Alterg has determined that the failure was due to a faulty ic. The ic was identified as suspect previously and has been substituted with alternative in may 2016. A hazard analysis of the reported problem was performed tht indicated the potential for failure can ext to occur (b)(4) uses of the product. There have been no reported injuries due to this event. Alterg will address the faulty component in the field via repair notice to all distributors and offer free replacement parts.
Patient Sequence No: 1, Text Type: N, H10
[77534953]
As reported by distributor: problem description: - new patient was in the m320, ready to start calibration - when pressing start, the treadmill did not calibrate but the treadmill went immediately to max speed. The belt did not stop when pulling the safety lanyard: emergency stop did not work! - patients shoe soles and shoe toes were seriously damaged by the abrasive belt. - the m320 could only be stopped by interrupting the power: this fast action by the therapist prevented the patient of being hurt. We did service the m300-0446 immediately: replacing the motor controller board 102647 did solve both problems: max. Speed and emergency stop.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007033433-2017-00001 |
| MDR Report Key | 6621552 |
| Date Received | 2017-06-08 |
| Date of Report | 2017-01-06 |
| Date of Event | 2017-04-04 |
| Date Mfgr Received | 2017-04-18 |
| Device Manufacturer Date | 2014-08-25 |
| Date Added to Maude | 2017-06-08 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR MICHAEL PHILLIPS |
| Manufacturer Street | 48438 MILMONT DRIVE |
| Manufacturer City | FREMONT CA 94538 |
| Manufacturer Country | US |
| Manufacturer Postal | 94538 |
| Manufacturer G1 | ALTERG, INC. |
| Manufacturer Street | 48438 MILMONT DRIVE |
| Manufacturer City | FREMONT CA 94538 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 94538 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ANTI-GRAVITY TREADMILL |
| Generic Name | MODEL M320 |
| Product Code | BXB |
| Date Received | 2017-06-08 |
| Model Number | M320 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| 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 | 2017-06-08 |