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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALTERG, INC. ALTER G ANTI-GRAVITY TREADMILL; EXERCISER, POWERED
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ALTERG, INC. ALTER G ANTI-GRAVITY TREADMILL; EXERCISER, POWERED Back to Search Results
Model Number M320
Device Problem Defective Device (2588)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/16/2019
Event Type  malfunction  
Event Description
The pt was placed into specialized shorts for the alter-g treadmill and assisted into the device.Pt stood in treadmill / device with the support bar raised and locked and the shorts attached to the device per protocol.The device was inflated to 100% to offload the pt's weight while standing.As the device inflated with air, pt heard and felt a rush of air escape from the machine; unable to determine immediately the source of the escaping air.Pt stood comfortably for a short period while adjustments were being made, and then she was unable to keep her footing as the treadmill band moved.Pt was unable to support her weight and her legs were no longer under her body, the alter-g did not support her weight as intended.She began to sink lower within the support beams and needed assistance from staff to safely get her out of the device.Fda safety report id# (b)(4).
 
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Brand Name
ALTER G ANTI-GRAVITY TREADMILL
Type of Device
EXERCISER, POWERED
Manufacturer (Section D)
ALTERG, INC.
fremont CA 94538
MDR Report Key8922934
MDR Text Key155694696
Report NumberMW5089258
Device Sequence Number0
Product Code BXB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 08/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/21/2019
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberM320
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Age39 YR
Patient Weight69
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