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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SUNRISE MEDICAL (US) LLC QUICKIE QM710; POWERED WHEELCHAIR

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SUNRISE MEDICAL (US) LLC QUICKIE QM710; POWERED WHEELCHAIR Back to Search Results
Model Number EIPW11
Device Problem Device Fell (4014)
Patient Problems Fall (1848); Bone Fracture(s) (1870); Concussion (2192); Joint Dislocation (2374)
Event Date 12/10/2019
Event Type  Injury  
Manufacturer Narrative
Per frank's boss, dave, when the chair flipped on its side it flipped onto its right side.Dave advised the end user dislocated and fractured his right shoulder.The concussion was stated to be mild so he is doing okay.Dave states nothing seems to be damaged on the right side from the accident.Dealer says he is unsure what caused the incident.Sunrise regulatory researched the history of this wheelchair and found no issue of this type previously recorded.The mother states in the complaint that her son was driving backwards while talking with this friends.The speed of the chair and the angle in which he drove off the paved area onto the grass is unknown.Warnings concerning obstacles and driving in reverse are stated in the wheelchair owner's manual.Page 9, section p.Obstacles states: riding over curbs or obstacles can cause tipping and serious bodily harm.If you have any doubt that you can safely cross any curb or obstacle, always ask for help.Be aware of your riding skills and personal limitations.Develop new skills with the help of a companion.Claus 2 states: keep your eyes moving when you ride; scan the area well ahead of your chair.Section q.Driving in reverse, states: use extra care when you drive your chair in reverse.You may lose control or fall if one of the rear wheels hits an object.Operate your chair slowly and at an even speed.Stop often and check to make sure your path is clear of obstacles.It is unlikely the wheelchair will be released to sunrise medical for inspection since the mother mentioned the family will possibly seek legal counsel.The dealer was unable to determine what may have caused the incident.He also could not confirm that a malfunction or defect occurred that may have caused or contributed to the incident.Sunrise medical regulatory and quality logically concluded that the incident occurred due to end user misuse and failure to follow instructions as previously listed from the owner's manual.However, if the wheelchair is released for evaluation and inspection, a follow up report may be filed with any new and relevant information.
 
Event Description
Dealer frank at national seating & mobility called to report that he received an email from an end user's mother stating, "jordan was driving backward talking to his friends.He drove off the sidewalk & on to the grass with a little dip.The wheelchair flipped over on the side.Jordan was in the wheelchair when it flip over on the side.Jordan has a fractured & dislocated shoulder & a slight concussion from the fall.".
 
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Brand Name
QUICKIE QM710
Type of Device
POWERED WHEELCHAIR
Manufacturer (Section D)
SUNRISE MEDICAL (US) LLC
2842 business park ave.
fresno CA 93727
Manufacturer (Section G)
SUNRISE MEDICAL (US) LLC
2842 business park ave.
fresno CA 93727
Manufacturer Contact
gustavo zambrano
2842 business park ave.
fresno, CA 93727
5592942840
MDR Report Key9588523
MDR Text Key175028310
Report Number2937137-2020-00004
Device Sequence Number1
Product Code ITI
UDI-Device Identifier05022408052363
UDI-Public05022408052363
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K083249
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 12/17/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model NumberEIPW11
Device Catalogue NumberEIPW11
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 12/17/2019
Initial Date FDA Received01/14/2020
Was Device Evaluated by Manufacturer? No
Date Device Manufactured06/14/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age12 YR
Patient Weight50
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