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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PRIDE MOBILITY PRODUCTS CORP. QUANTUM 4FRONT POWER WHEELCHAIR; WHEELCHAIR, POWERED
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PRIDE MOBILITY PRODUCTS CORP. QUANTUM 4FRONT POWER WHEELCHAIR; WHEELCHAIR, POWERED Back to Search Results
Model Number 4 FRONT
Device Problems Break (1069); Device Slipped (1584); Component Missing (2306)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/10/2020
Event Type  malfunction  
Event Description
I received a replacement power wheelchair from pride/quantum that is "rated for wc19 compliance" but the chair has loose bolts, brackets missing parts, stripped bolt heads, the left side motor/brake isn't connected properly and doesn't keep the chair stopped.And other issues that make it unsafe to use.The reason they sent this replacement chair, is when we (b)(6) healthcare ordered my new chair.Somehow the "occupied transport" option wasn't installed when the chair was built.The same wc-19 took them about 4 months to decide that it would be easier to replace the entire chair, than it would be to retrofit mine so they sent me this current one, with all of its problems.I drive my van from my chair, and it needs to have the occupied transport rating.Quantum claims this chair is compliant but it's clearly missing parts.There are more photos but i'm only including a few due to file size.Fda safety report id#: (b)(4).
 
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Brand Name
QUANTUM 4FRONT POWER WHEELCHAIR
Type of Device
WHEELCHAIR, POWERED
Manufacturer (Section D)
PRIDE MOBILITY PRODUCTS CORP.
MDR Report Key9967298
MDR Text Key188282544
Report NumberMW5094154
Device Sequence Number1
Product Code ITI
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 04/13/2020
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received04/15/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number4 FRONT
Was Device Available for Evaluation? Yes
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
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