MAUDE Adverse Event Report: SUNRISE MEDICAL (US) LLC QUICKIE PULSE 6 BC; WHEELCHAIR POWERED

Model Number	EIPW22
Health Effect - Clinical Codes	Bruise/Contusion (1754); Fall (1848)
Date of Event	06/23/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Sunrise medical has opened an investigation of this incident.The dealer (b)(6), did not mention if any testing was performed on the joystick by them.However, she is returning the joystick to sunrise medical for an evaluation.It is currently not possible to determine if there was a malfunction or defect in the product with the little information that was provided.Once the product is returned and an evaluation is performed, a supplemental report will be filed with any relevant findings.Please note this mdr filing, along with mdr 2937137-2017-00019 are submitted 6 days late due to system issues with the esubmitter and webtrader.Worked with the following help desks since 8/3/2017 to fix the issues: (b)(4).
Event or Problem Description
On (b)(6) 2017 dealer (b)(6) called for a replacement joystick quote.(b)(6) stated the chair moved on its own.She stated the chair was on a ramp and it backed off on its own and fell with the client in it and landed on the client.She stated per the mother, there was some bruising only.When leanne saw the end user, she said there were some scabs present.To (b)(6) knowledge there was no doctor's visit and no hospitalization.(b)(6) was not sure of the original date of the incident but thought it might have been (b)(6).

• Brand Name: QUICKIE PULSE 6 BC
• Common Device Name: WHEELCHAIR POWERED
• Manufacturer (Section D): SUNRISE MEDICAL (US) LLC; 2842 business park ave.; fresno CA 93727
• MDR Report Key: 6786823
• Report Number: 2937137-2017-00020
• Device Sequence Number: 11155687
• Product Code: ITI
• UDI-Device Identifier: 05022408051977
• UDI-Public: 05022408051977
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K142457
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: EIPW22
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2017
• Initial Report FDA Received Date: 08/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 54