MAUDE Adverse Event Report: SUNRISE MEDICAL (US) LLC QUICKIE S636; WHEELCHAIR, POWERED

Model Number	EIS62
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/16/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Sunrise medical has opened an investigation of this incident.It was determined that if the part has malfunctioned and if a similar incident were to reoccur, it could possibly cause or contribute to a serious injury or death.However, at this time it is unknown if the product has malfunctioned, since we have not received the part back for evaluation yet.Therefore, sunrise medical came to the decision to file the mdr and after we received the part and an evaluation is performed, a supplemental report will be filed with our findings.A new replacement joystick was shipped to the dealer on 7/3/2017.
Event or Problem Description
Dealer matt stated that the joystick is turning on by itself and going in reverse.He says the chair will do this intermittently.The dealer also stated the chair ran over a little girl's foot.As per matt, no injuries occurred as a result of this.
Additional Manufacturer Narrative
Sunrise medical received the item and a quality inspector performed a preliminary evaluation on 9/12/17.The result of the preliminary evaluation was that the failure could not be duplicated after several function tests.The remote performed to specifications.A full evaluation was performed on 10/20/17.It was again concluded that the item performed to specifications.The joystick was plugged into a chair for a number of days with no observed movement or activation of the chair.The result of the full evaluation was that the failure could not be duplicated.
Event or Problem Description
Please see initial mdr 2937137-2017-00016.

• Brand Name: QUICKIE S636
• Common Device Name: WHEELCHAIR, POWERED
• Manufacturer (Section D): SUNRISE MEDICAL (US) LLC; 2842 business park ave.; fresno CA 93727
• MDR Report Key: 7043547
• Report Number: 2937137-2017-00016
• Device Sequence Number: 3475004
• Product Code: ITI
• UDI-Device Identifier: 05022408044252
• UDI-Public: 05022408044252
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K981462
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2017

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: EIS62
• Device Catalogue Number: EIS62
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/16/2017
• Supplement Date Received by Manufacturer: 10/20/2017
• Initial Report FDA Received Date: 11/17/2017
• Supplement Report FDA Received Date: 11/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1