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

Model Number	EIPW11
Health Effect - Clinical Codes	Bruise/Contusion (1754); Fall (1848); Injury (2348)
Date of Event	10/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
After receiving very limited information from the dealer, sunrise medical's customer service representative attempted to contact the dealer to obtain additional information.After sending two emails to the dealer, he replied that he could not provide any more information.The dealer provided the end user's contact information stating it was not his responsibility to gather the additional information sunrise medical asked of him.Sunrise medical then attempted to contact the end user, however was unsuccessful.A voice message was left for the end user explaining our need for additional information in order to attempt to find the root cause of the alleged parts failure and incident.The end user has not responded to our contact attempt to date.The failure of the gas struts is a known issue that was addressed in capa (b)(4).Testing was performed by (b)(6) at 11:30am on (b)(6) 2016, which concluded that the qm7-series wheelchair operates normally and safely with only a single side of the suspension functioning properly.It is most likely that one suspension started to degrade before the other (as has been seen in historical data of strut failures).It is also likely that the end user may have continued to use the chair with one failed gas strut (which is commonly seen amongst user reports) and then the second gas strut may have failed before the alleged fall from the chair occurred.The chair was originally equipped with a positioning belt.It is stated in the user's manual (pg.12, clause j) the positioning belt is predominately used to support your posture.It can also be used to limit slipping and/or sliding that you might experience when the chair is in motion.However, there is no indication that the user was using the positioning belt and there is a known lack of compliance in many users who fail to use their positioning belts as recommended in the user's manual.In regards to properly maintaining the wheelchair, the following warning is provided in the user'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).Replacement gas struts were shipped to the dealer on 10/11/2018.The dealer was provided with return authorization number (b)(4) in order to return the old gas struts, however we have not received them yet.With the dealer unable to provide any additional information regarding the circumstances in which the alleged incident occurred, the parts not being returned and no contact from the end user to return sunrise medical's phone calls, a thorough evaluation and inspection for this specific wheelchair is not possible at this time.Therefore, determining the root cause for the alleged failure of the gas struts cannot be reached.Although there was no serious injury to report, out of an abundance of caution, sunrise medical has decided to file this mdr.If and when additional relevant information is provided to sunrise medical, a supplemental report will be filed.There will be no further investigation performed by sunrise medical at this time.
Event or Problem Description
On (b)(6) 2018 dealer, (b)(4), stated the struts had no tension and the end user was thrown from the chair.(b)(4) received the call on (b)(6) 2018.Per the dealer the user got a little "banged up" and did go to the hospital.The dealer also states the end user had a big bruise on the right leg and is a left below the knee amputee.

• Brand Name: QUICKIE QM710
• Common Device Name: POWERED WHEELCHAIR
• Manufacturer (Section D): SUNRISE MEDICAL (US) LLC; 2842 business park ave.; fresno CA 93727
• MDR Report Key: 8044323
• Report Number: 2937137-2018-00015
• Device Sequence Number: 1539966
• Product Code: ITI
• UDI-Device Identifier: 05022408052363
• UDI-Public: 05022408052363
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 10/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: EIPW11
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2018
• Initial Report FDA Received Date: 11/06/2018
• Patient Sequence Number: 0
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Weight: 70