MAUDE Adverse Event Report: SUNRISE MEDICAL (US) LLC QUICKIE PULSE; POWER WHEELCHAIR

Model Number	QUICKIE PULSE
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Laceration(s) (1946); Joint Dislocation (2374)
Date of Event	10/30/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Dealer reports that the end user and wheelchair were hit by a small truck while driving on the street.The end user reports he allegedly experienced a dislocated shoulder and a laceration on his leg that required 20 stitches.He is currently receiving ongoing treatment for the reported injuries.
Additional Manufacturer Narrative
Background information: quickie pulse owner's manual, rev h states: "warning! 1.This product is not intended for street use.Avoid streets whenever possible.2.Obey and follow all legal pedestrian pathways, and laws that apply to pedestrians.3.Be alert to the danger of motor vehicles in parking lots, or if you must cross a road.4.It may be hard for drivers to see you.Make eye contact with drivers before you proceed.When in doubt, yield until you are sure it is safe." discussion: in reviewing the complaint, the dealer reports that the end user and wheelchair were hit by a small truck while driving on the street.This incident occurred in the early morning hours (6:00am).There is limited information available because the end user states that he only remembers when he woke up in an ambulance after the event.There are no details in relation to the layout and conditions of the street where the end user was struck.There is no indication that a product issue occurred.The end user reports he allegedly experienced a dislocated shoulder and a laceration on his leg that required 20 stitches during the incident.He is currently receiving ongoing treatment for the reported injuries.Conclusion: due to the allegation of serious injuries that require medical intervention (stitches and ongoing follow up treatment with a primary care physician), this mdr is being filed.

• Brand Name: QUICKIE PULSE
• Common Device Name: POWER WHEELCHAIR
• Manufacturer (Section D): SUNRISE MEDICAL (US) LLC; 2842 n business park avenue; fresno CA 93727 1328
• Manufacturer (Section G): SUNRISE MEDICAL (US) LLC; 2842 n business park avenue; fresno CA 93727 1328
• Manufacturer Contact: christian stephens ; 2842 n business park ave; fresno, CA 93727 ; 5592942374
• MDR Report Key: 15909643
• Report Number: 2937137-2022-00013
• Device Sequence Number: 6096973
• Product Code: ITI
• UDI-Device Identifier: 00016958051971
• UDI-Public: (01)00016958051971
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K083249
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/02/2022

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: QUICKIE PULSE
• Device Catalogue Number: EIPW22
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/02/2022
• Initial Report FDA Received Date: 12/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/28/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 48 YR
• Patient Sex: Male
• Patient Weight: 98 KG