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

Model Number	EIPW11
Health Effect - Clinical Code	Head Injury (1879)
Date of Event	10/22/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A similar incident has been reported and investigated.It was found that the previously reported incident was a result of the seat lock knobs not properly fastened or reinstalled into the seat base by the dealer's service technician.The failure was not due to a product malfunction or defect.The current incident mirrors the findings in the previous incident.The knobs are equipped with a lanyard attached to keep the knobs from being misplaced or lost by the service technician.This has been documented in the product's ufmea and is being monitored for trends.Currently the occurrence rating is 3 which is equivalent to "improbable" that a similar type of incident is likely to occur.It is likely that the lanyard was removed from the seat lock knobs and the knobs were not properly tightened, as which was the case of the previous incident that was reported on mdr 2937137-2013-00019.It does state on page 14, section h of the wheelchair's owner's manual: "check knobs under the front of the seat for proper tightness weekly".It is also stated on page 17, section q, point f: "after replacing the batteries ensure that the knobs are reinstalled and tightened securely".This incident appears to mirror the known incident previously investigated and, therefore, does not warrant additional investigation by sunrise medical at this time.
Event or Problem Description
Per dealer (b)(6), on (b)(6) 2018 the end user was in the chair using the tilt function and the chair fell completely back.This incident occurred at home and the patient was injured.They had to go to the er for an open gash on the back of the end user's head.(b)(6) stated the hex screw fell out of the base of the seat causing the incident to occur.(b)(6)stated that the chair does not need to be returned, they have ordered all replacement parts needed.

• 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: 8162914
• Report Number: 2937137-2018-00018
• Device Sequence Number: 2025457
• Product Code: ITI
• UDI-Device Identifier: 05022408052363
• UDI-Public: 05022408052363
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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): 11/16/2018

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: 11/16/2018
• Initial Report FDA Received Date: 12/13/2018
• 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: Required Intervention
• Patient Weight: 79