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

Model Number	EIPW11
Health Effect - Clinical Code	Fall (1848)
Date of Event	08/03/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On 8/3/2018 sunrise medical received additional information from account manager, (b)(4) regarding the incident.(b)(4) stated, "i was able to speak with the local (b)(6) branch and their service tech.It appears the end user broke one or multiple ribs, along with some facial contusions.As far as the chair; on (b)(6) 2018 (b)(6) ordered replacement caster parts.They shipped the parts to the end user due to remote location to have user install.The end user was unable to remove the original parts, so scheduled an appointment at (b)(6) to have the tech install, which he installed in (b)(6) 2018.Apparently there were hammer indentations all over the top of the swing arms the (b)(6) tech noticed prior to the install of the replacement forks, etc.The (b)(6) tech believed the end user (and his buddies) tried to beat the original forks out with a hammer, but was unsuccessful, as they didn't realize there is a retaining ring below the bottom housing bearing.The branch stated they do not have any of the front fork assemblies, and nothing appears to be left in the front swing arm.He did say there was an oily substance all over the inside of the swing arms, as if it was sprayed with (b)(4) or another lubricant.Appears this is from abuse and/or neglect and not a manufacture defect." it was confirmed to sunrise medical with photos provided by the dealer that the front casters were completely missing from the front swing arm assemblies.The arm assemblies clearly show the markings where the caster assemblies were hammered out by the end user.Since the dealer is unable to provide the missing caster assemblies for further evaluation, sunrise medical considers this product failure to be due to end user abuse.There will be no further investigation performed by sunrise medical.
Event or Problem Description
Sunrise medical account manager reported that an end user was operating the chair on the street when both front casters came off the chair and the end user was thrown out of the chair.The end user was taken by ambulance to the hospital.

• 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: 7824543
• Report Number: 2937137-2018-00011
• Device Sequence Number: 1287034
• Product Code: ITI
• UDI-Device Identifier: 05022408052363
• UDI-Public: 05022408052363
• Combination Product (Y/N): N
• Initial Reporter State: SD
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 08/03/2018

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/03/2018
• Initial Report FDA Received Date: 08/28/2018
• 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 Weight: 93