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

Model Number EIPW11

Device Problem Device Fell (4014)

Patient Problems Fall (1848); Bone Fracture(s) (1870)

Event Date 10/24/2019

Event Type  Injury  

Manufacturer Narrative

Sunrise medical regulatory attempted to contact dealer, (b)(6) to obtain additional information regarding this incident.A phone call was placed to (b)(6) on (b)(6) 2019 and was followed up via email on that same day.The voice message that was left for billy and the follow up email contained questions that required his response in order to properly investigate this matter.However, to date there has been no response to either the phone call or email.Sunrise medical regulatory researched the history of this chair and found there were service parts orders where it was commented by the same dealer that the end user is a college student and is "very hard" on the chair and drives "heavily in all outdoor conditions." on two different occasions, (b)(6) 2017 and (b)(6) 2018, replacement gas struts were requested.There was no adverse event reported on either of the two occasions.On (b)(6) 2019 the same dealer contacted sunrise medical to request a replacement lift/tilt assembly that was damaged.There was no allegation of malfunction or defect made.It is likely the item was damaged due to the "heavily" and "hard" usage of the wheelchair as previously stated by the dealer.Again, no adverse event was reported at that time as well.At this time, it is unknown if both gas struts failed on this chair since the dealer has not responded to sunrise medical's contact attempts.The failure with the gas struts is a known issue that was addressed in capa (b)(4).If both gas struts failed, it is likely that one suspension started to degrade before the other.Testing of like item gas struts, performed on (b)(6) 2016 has revealed that the wheelchair operates normally and safely with only a single side of the suspension functioning properly.It is reasonable to conclude that in this instance, it is likely that one of the gas struts may have failed first and the end user continued to operate the wheelchair in that condition until the other strut failed which then led to the adverse event.In regards to properly maintaining the wheelchair, the following warning is provided in the owner's manual (pg.25, clause a, item 2) which states "if you have discovered a worn, bent or damaged part, repair or replace them with recommended parts before returning this chair to service." it is also stated in the owner's manual, specific to the springs, "if the springs need replacing, contact sunrise medical customer service for parts and service information" (pg.11, clause i, item 3).In regards to the dealer's previous statement where it is mentioned that the end user operates the wheelchair heavily in all conditions, the owner's manual also warns in regards to operating the wheelchair on certain terrain.(pg.8, clause i, item 3) states, "do not operate the chair on sand, loose gravel or soil.Doing so may damage wheels, bearings, axles, motors or loosen fasteners." (b)(6) did advise sunrise medical's account manager, derek wenzel that he was arranging to retrieve the wheelchair from the end user for evaluation and would provide him with a loaner chair.To date, sunrise medical has not heard from the dealer and is not aware if the dealer has retrieved the wheelchair.Sunrise medical will continue making attempts to reach out to the dealer.If and when the dealer provides any new relevant information, a follow up report may be filed.

Event Description

Per dealer, (b)(6) client claims he was driving the chair and when he stopped the front casters were up in the air.User claims the chair rocked forward when he stopped and the client fell forward.Client claims he was secured into chair with seat belt and claims the chair fell on top of him.Client claims to have suffered multiple breaks/fractures in both legs.

• 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 Key: 9358677
• MDR Text Key: 169827065
• Report Number: 2937137-2019-00026
• Device Sequence Number: 1
• Product Code: ITI
• UDI-Device Identifier: 05022408052363
• UDI-Public: 05022408052363
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083249
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/24/2019

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 Number: EIPW11
• Device Catalogue Number: EIPW11
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/24/2019
• Initial Date FDA Received: 11/21/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/18/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 73