MAUDE Adverse Event Report: SUNRISE MEDICAL (US) LLC QUICKIE P222; POWERED WHEELCHAIR

Model Number	EIPW2
Health Effect - Clinical Code	Injury (2348)
Date of Event	12/04/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Sunrise medical received an update that the end user will remain in the hospital possibly for several months.Arrangements to have the wheelchair returned to sunrise medical for a full inspection and evaluation have been made.Although the dealer was unable to provide any details about how the accident occurred or the type of injury/injuries sustained, sunrise medical has decided to file the mdr.There were no allegations of malfunction or defect made against the wheelchair.Upon completion of the wheelchair evaluation, a supplemental report may be filed if any new or relevant information is found.
Event or Problem Description
Per the dealer, (b)(6), he performed an evaluation of the chair on (b)(6) and reported that the chair was involved in a car accident previous to that evaluation.The end user was in the chair when the chair was hit by a car.The patient was dragged by the car and was hospitalized.The extent of the end user's injuries is unknown.

• Brand Name: QUICKIE P222
• Common Device Name: POWERED WHEELCHAIR
• Manufacturer (Section D): SUNRISE MEDICAL (US) LLC; 2842 business park ave.; fresno CA 93727
• MDR Report Key: 9539661
• Report Number: 2937137-2020-00001
• Device Sequence Number: 16746223
• Product Code: ITI
• UDI-Device Identifier: 05022408043415
• UDI-Public: 05022408043415
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K963385
• 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): 12/04/2019

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: EIPW2
• Device Catalogue Number: EIPW2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2019
• Initial Report FDA Received Date: 01/02/2020
• 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: 82