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

Model Number	EIPW11
Health Effect - Clinical Code	Injury (2348)
Date of Event	08/20/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
In an attempt to gather additional information regarding this incident, (b)(6) placed a call to (b)(6), the dealer.He did not answer the call and a voice message was left for him to return the call in order to gather the additional information needed to properly complete the investigation.To date, (b)(6) has not returned the phone call.Another attempt was also made by sunrise medical's account manager, collin mcmannis to obtain information from the dealer, however was unsuccessful.Since sunrise medical was unable to reach the dealer for information on the occurrence of the incident, sunrise medical's regulatory specialist researched the service history of this wheelchair.It was found that on 11/26/18, it was reported by the same dealer, (b)(6) that the end user requested a quote for a replacement arm mount because it had broken.(b)(6) stated the end user fell out of the chair when attempting to go down a ramp when she lost control of the chair.The end user suffered a hairline fracture to her foot, bruised rib and a dislocated kneecap.This incident was reported on mdr 2937137-2018-00019.There was no allegation of malfunction or defect made against the wheelchair at that time.Similar to the incident from (b)(6) 2018, there was also no allegation of malfunction or defect made against the wheelchair in this recent incident.It was simply stated that the arm rest shoulder bolt broke but the circumstances in which it broke was not provided.In an effort to come to a reasonable determination as to the root cause of the incident, sunrise medical's regulatory department is continuing the investigation and making additional attempts to reach the dealer.With the information gathered up until now, sunrise regulatory has determined that the most likely cause for both incidents is customer misuse.It is likely that the bolt may have damaged by using the armrests to maneuver the chair during use or while it was being serviced.Another likely occurrence is that the bolt was damaged from the (b)(6) 2018 incident and ultimately failed in this incident.It is stated in the wheelchair's owner's manual on page 11, section a.Armrests: 1.Armrests will not bear the weight of this chair.2.Never lift this chair by its armrests.They may come loose or break.Therefore, this information will be recorded in the device ufmea and will be monitored for trends.If additional relevant information is provided by the dealer that changes the assigned root cause, a supplemental report may be filed.
Event or Problem Description
Dealer, jesse stated that the end user claimed she injured herself because the right armrest shoulder bolt broke and the armrest broke off.Jesse also stated that the end user claimed she broke her left leg and now is in a cast.

• 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: 9088299
• Report Number: 2937137-2019-00024
• Device Sequence Number: 409166
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/20/2019

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
• Operator of Device: Lay User/Patient
• Device Model Number: EIPW11
• Device Catalogue Number: EIPW11
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2019
• Initial Report FDA Received Date: 09/19/2019
• 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; Required Intervention
• Patient Age: 48 YR
• Patient Weight: 73