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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SUNRISE MEDICAL (US) LLC QUICKIE SERIES MANUAL WHEELCHAIR; WHEELCHAIR, MECHANICAL
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SUNRISE MEDICAL (US) LLC QUICKIE SERIES MANUAL WHEELCHAIR; WHEELCHAIR, MECHANICAL Back to Search Results
Model Number ELZ4-2
Device Problems Device Tipped Over (2589); Unintended Movement (3026)
Patient Problem Fall (1848)
Event Date 06/08/2018
Event Type  malfunction  
Event Description
Middle-aged male with diabetes mellitus, multiple back surgeries with spinal cord stimulator, hypertension, reflex sympathetic dystrophy, fibromyalgia admitted to rehab hospital with bilateral lower extremity weakness/neuropathy with deficits in self-care and mobility.Patient utilizing a quickie iris tilt-in-space wheelchair.Patient was found half-way out of the wheelchair in a flipped forward position (legs/feet still in wheelchair but upper torso and arms forward onto the bed).Patient reported the wheelchair "flipped" forward, causing the patient to fall out of the chair.No injuries were sustained.
 
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Brand Name
QUICKIE SERIES MANUAL WHEELCHAIR
Type of Device
WHEELCHAIR, MECHANICAL
Manufacturer (Section D)
SUNRISE MEDICAL (US) LLC
2842 business park avenue
fresno CA 93727
MDR Report Key7693568
MDR Text Key114161043
Report Number7693568
Device Sequence Number1
Product Code IOR
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Nurse
Type of Report Initial
Report Date 07/12/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/17/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberELZ4-2
Device Catalogue NumberELZ4-2
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/12/2018
Event Location Hospital
Date Report to Manufacturer07/17/2018
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Age16425 DA
Patient Weight104
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