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

Model Number	QUICKIE PULSE
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Pain (1994); Blister (4537); Unspecified Tissue Injury (4559)
Date of Event	07/26/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2022, the sunrise medical legal department received a complaint in a civil action.The plaintiff alleges in her complaint that she was not fitted correctly for the wheelchair ordered on her behalf.Plaintiff alleges that while putting the chair in tilt mode, she allegedly experienced a blood blister on the back of her right calf.Plaintiff also reports that a deep pressure wound allegedly occurred unbeknownst to her.Plaintiff was treated at a hospital and a rehabilitation center from (b)(6) 2020 through (b)(6) 2020.Plaintiff also alleges she experienced excruciating back pain.The serial number was not reported in the complaint, but sunrise has identified the plaintiff as an individual for whom a sunrise wheelchair product was marked.No further information has been provided in regards to the reported injuries and treatment.This case is currently in litigation.
Additional Manufacturer Narrative
Background information: quickie pulse owner's manual, rev.G states: "a.Choose the right chair & safety options sunrise provides a choice of many power wheelchair styles, sizes and adjustments to meet the needs of the user.However, final selection of a wheelchair rests solely with you and your health care professional.Choosing the best chair for you depends on such things as: 1.Your size, disability, strength, balance and coordination.2.Your intended use, and your level of activity.3.The types of hazards you must overcome in daily use (in areas where you are likely to use your chair).4.The need for options for your safety and comfort (such as positioning belts or special seat systems)." quickie pulse owner's manual, rev.G states: "3.Pinch points pinch points may occur when operating the powered seating options on this chair.Ensure all hands and body parts are clear of all power seating components that may result in pinch points before operating them." discussion: because the lawsuit does not describe how putting the wheelchair in tilt mode caused the plaintiff to experience a blood blister or develop a pressure wound, the root cause of the injury cannot be determined at this time.Based on the limited information available at this time, a potential cause is that the wheelchair was not fitted correctly to plaintiff.Plaintiff's complaint alleges her dealer and occupational therapist ordered a wheelchair that was not appropriate for her needs.The end user claims multiple issues with the fit of the wheelchair.It is reported that the chair ordered for her was too big, the arm rest was too short, the footrest was too heavy, and the back of the chair was uncomfortable.Plaintiff alleges that she chose not to use her wheelchair for a couple of years until her previous wheelchair became unreliable.Plaintiff alleges in her complaint that while putting the wheelchair in tilt mode, she allegedly experienced a blood blister on the back of their right calf and that unbeknownst to her a deep pressure wound occurred.She alleges she received treatment from multiple health care facilities, including hospitals and rehabilitation centers for her alleged injuries.The end user also alleges that she experienced excruciating back pain while using the chair.Plaintiff alleges that one of her health care providers was able to make changes to her wheelchair to prevent further injury and were able to submit an order to replace the back of the wheelchair.There are no further details regarding the alleged injuries or treatment nor the modifications made to the wheelchair.With incorrect fitting, there is a potential that the wheelchair could pinch or press the plaintiff due to the wheelchair not lining up appropriately with the plaintiff's body.Without further information at this time, sunrise cannot evaluate whether plaintiff was properly fitted for her chair or not, but that potential cause seems plausible because replacing the back and modifying the chair has seemingly prevented further injury.It is the responsibility of an end user and their healthcare professional to order an appropriately fitted chair.Conclusion: this is a preliminary evaluation, necessarily limited because the matter is in litigation.Because a serious injury was alleged (deep pressure wound), an mdr is being filed out of an abundance of caution.

• 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: 15481014
• Report Number: 2937137-2022-00012
• Device Sequence Number: 5620616
• Product Code: ITI
• UDI-Device Identifier: 00016958051971
• UDI-Public: (01)00016958051971
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/23/2022

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?: Yes
• 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: 08/24/2022
• Initial Report FDA Received Date: 09/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2016
• 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; Hospitalization
• Patient Sex: Female