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

Model Number	PULSE
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fall (1848); Laceration(s) (1946)
Date of Event	11/05/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Background information: quickie pulse owner's manual, page 9, "warning! reaching or leaning affects the center of balance of your chair.If done improperly, a fall or tip-over is likely.When in doubt, ask for help or use a device to extend your reach." quickie pulse owner's manual, page 9, "warning! it is dangerous to transfer on your own.It requires good balance and agility.Be aware that there is a point during every transfer when the wheelchair seat is not below you.To prevent a fall: 6.Be careful of the footrests.If you can, remove or swing them out of the way.As a standard rule, never stand on footrests when you transfer.Doing so may damage them or cause your chair to tip.If the footplate is in contact with the ground, it is possible to use the footplate for a transfer.Make sure your feet do not "hang up" or get caught in the space between the footrests." quickie pulse owner's manual, page 11, "2.To avoid a trip or fall when you transfer: · make sure your feet do not "hang up" or get caught in the space between the footrests avoid putting weight on the footrests, as the chair may tip forward.Remove or swing the footrests out of the way, if possible." discussion: in reviewing the complaint, the end user reports that she allegedly fell after standing up to reach the sink and turning to the right, tripping over the right footplate of her wheelchair.The leg rests were locked into place during this incident.The end user reports that when she fell over, she allegedly hit the edge of the footplate and caused a large laceration on her right leg in the shin area.The user also reports in a separate call that she allegedly hit her head underneath the headrest, causing her to be knocked unconscious and cut her foot during this incident.She was taken to the hospital and reportedly had a 5-6 month healing process for the wounds.The healing process allegedly consisted of wound care for the laceration on her right leg since stitches were not possible.The end user reports that she is currently experiencing burning sensations, flaring and has two puncture holes on her legs.There is no indication that the wheelchair malfunctioned or that it didn't perform as intended.Based on the information provided, the end user most likely lost her center of balance while standing up and reaching for the sink.The leg rests/footplate are made of metal, so significant force impacted against those parts on the wheelchair can potentially lead to harm.The owner's manual for the quickie pulse warns against improper reaching or leaning, suggesting that a user ask for help or use a device to extend their reach to avoid a fall or tip over.Conclusion: while there is no indication of a product malfunction (i.E., the device performed as intended), a serious injury occurred, so out of an abundance of caution, an mdr is being filed.
Event or Problem Description
End user reports that she allegedly fell after standing up and turning to the right, tripping over the right footplate of her wheelchair.The end user reports that when she fell over, she allegedly hit the edge of the footplate and caused a large laceration on her right leg in the shin area.The user also reports in a separate call that she allegedly hit her head underneath the headrest and cut her foot during this incident.She was taken to the hospital and reportedly had a 5-6 month healing process for the wounds.

• 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: 14853342
• Report Number: 2937137-2022-00009
• Device Sequence Number: 12073531
• Product Code: ITI
• UDI-Device Identifier: 00016958051971
• UDI-Public: (01)00016958051971
• Combination Product (Y/N): N
• 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): 06/29/2022

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: PULSE
• Device Catalogue Number: EIPW22
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/01/2022
• Initial Report FDA Received Date: 06/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2018
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 122 KG