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

Model Number	EIPW11
Health Effect - Clinical Codes	Fall (1848); Bone Fracture(s) (1870)
Date of Event	03/17/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Sunrise medical has opened an investigation of this incident.The dealer states that the chair has been in their shop.Dealer also states they have driven it around and tested it and nothing seems to be wrong with the chair.Arrangements have been made with the dealer to have the wheelchair returned to sunrise medical for a full evaluation.The end user is currently using another chair.A follow up report will be filed with any new relevant information from the evaluation results.Per (b)(6) at fda medwatch, sunrise medical is filing a 2nd initial mdr 2937137-2017-00010 due to the original mdr, which was submitted on 5/1/2017 could not be located.A supplemental mdr report 2937137-2017-00010-1 was filed and received by fda medwatch on 7/11/2018.
Event or Problem Description
Per dealer, end user reported an adverse incident that occurred on (b)(6) 2017 while in a qm710 power chair.End user states he was driving the chair on the sidewalk when the right side drive wheel/motor allegedly froze which then caused him to fall out of the chair.The end user stated he received a fractured foot/toe due to the fall.
Event or Problem Description
Please see initial mdr 2937137-2017-00010.
Additional Manufacturer Narrative
This incident was reported to the fda on mdr 2937137-2017-00010 with a follow up pending the evaluation of the alleged failed wheelchair.The subject wheelchair was returned to sunrise medical (us) llc on 5/8/2017.However, since the incident was escalated to a legal case, sunrise medical was instructed by legal counsel that a thorough destructive evaluation could not be performed but a visual inspection was allowed.On may 10, 2017 sunrise medical's quality inspector performed a visual inspection and recorded the following: "we found that the link arm bolt has stripped out, therefore the right side suspension was not working correctly.Damage found on bottom of chair.Scrapes on the right side bottom indicate chair has dragged on ground or curb.The link arm has also done the normal damage to the bottom of gearbox, but may not be a contributing factor to the issue.Damage was found to right side arm rest.Rolled and bent slightly, joystick arm has been smashed some on the back end.Power center mount has loose bolts on the top and is scraped some.No issue found with operation of motors and gearboxes.This is our preliminary evaluation.Tear down will be required to evaluate further for detailed failure determination.Current analysis coded as customer abuse." being that the subject wheelchair was involved in a legal action case and a thorough evaluation could not be performed, this inspection at the time could not be verified and reported as factual information.Sunrise medical's regulatory department was given notice on 4/12/2018 that the legal case involving the subject wheelchair had come to a conclusion and a thorough destructive evaluation could now be performed.A 2nd and complete evaluation was performed by sunrise medical's r&d engineer and quality engineer with a conclusion provided to regulatory on june 18, 2018.The evaluation stated the following: analysis: a second evaluation was performed by sunrise medical engineers on 6/5/18.The power wheelchair was gently placed on its side so the motor and mid link could be clearly visible.It was observed that the right mid link arm was caught so the suspension did not articulate.This would cause the right side to become rigid, giving the "feeling" the drive wheel/motor froze.The mid link became caught because the bolt backed out.Resolution: mpse 11027 updated the bolt to a longer length and added a nut on the back to prevent backing out.Conclusion: all that was reported in the initial visual inspection performed on may 10, 2017 was confirmed and concluded that there was no issue found with the operation of the motors and gearboxes.No further investigation will be performed by sunrise medical (us) llc.

• Brand Name: QUICKIE QM710
• Common Device Name: WHEELCHAIR POWERED
• Manufacturer (Section D): SUNRISE MEDICAL (US) LLC; 2842 business park ave.; fresno CA 93727
• MDR Report Key: 7678521
• Report Number: 2937137-2017-00010
• Device Sequence Number: 3170916
• Product Code: ITI
• UDI-Device Identifier: 05022408052363
• UDI-Public: 05022408052363
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K083249
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2018

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
• Operator of Device: Lay User/Patient
• Device Model Number: EIPW11
• Device Catalogue Number: EIPW11
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2017
• Initial Date Received by Manufacturer: 04/03/2017
• Supplement Date Received by Manufacturer: 06/18/2018
• Initial Report FDA Received Date: 07/11/2018
• Supplement Report FDA Received Date: 07/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 54 YR
• Patient Weight: 102