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

Model Number	PULSE
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Head Injury (1879)
Date of Event	07/13/2021
Type of Reportable Event	Death
Additional Manufacturer Narrative
Background information: quickie pulse owner manual (p/n: 119832, rev h) statements: "p.Obstacles: warning! riding over curbs or obstacles can cause tipping and serious bodily harm.If you have any doubt that you can safely cross any curb or obstacle, always ask for help.Be aware of your riding skills and personal limitations.Develop new skills only with the help of a companion.1.Be aware that thresholds are very dangerous.(even a small change in height may stop a caster wheel and cause your chair to tip)." "v.Curbs & single steps: warning! sunrise recommends that you avoid climbing and/or descending a curb, single step, or other obstacle, and that a ramp or curb cutout is always used.If you must climb or descend a curb, single step, or other obstacle that is greater than 2.5", it is recommended to have a person assist you in doing so.Do not try to climb a curb, single step, or other obstacle greater than 4" high.If you must climb or descend a curb or step alone do so at your own risk using extreme care and use the following procedure: ¿ proceed slowly, at a steady speed ¿ go as straight up or down as you can over the obstacle.Never turn when trying to climb or descend an obstacle, doing so may result in a fall or tip-over.Failure to follow the above recommendations may cause: ¿ a fall or tip over ¿ damage to the frame, wheels, axles or other parts, or loose fasteners." discussion: it appears that the wheelchair user may have used the chair in an unsafe manner (as prohibited in the owner manual) and the dealer could find no malfunction of the wheelchair itself.Damage done to the wheelchair was determined to be a result of the tip over and not the cause.Conclusion: this was a tragic accident, not caused by any wheelchair malfunction.Therefore, there is no malfunction to report; however, this incident is being reported due to the nature of the result of the injury being death.
Event or Problem Description
The original purchaser (consumer) of this wheelchair died at a previous unknown date, unrelated to the wheelchair.The widow loaned the wheelchair to another male (no details of who this was--adult or juvenile).It is unknown whether this male was provided the owner manual for the wheelchair.The wheelchair user allegedly went off a curb at an angle (rather than straight forward) which caused the wheelchair to tip over.The user then hit his head on the concrete and later died.The dealer representative believes (after talking with the widow) that the user misjudged the curb and found no malfunction with the wheelchair (worked as intended with no unintended motion issues found).

• Brand Name: QUICKIE PULSE
• Common Device Name: POWER WHEELCHAIR
• Manufacturer (Section D): SUNRISE MEDICAL (US) LLC; 2842 n business park ave; fresno CA 93727
• MDR Report Key: 12366272
• Report Number: 2937137-2021-00041
• Device Sequence Number: 4535387
• Product Code: ITI
• UDI-Device Identifier: 00016958051971
• UDI-Public: (01)00016958051971
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/25/2021

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: Other
• Device Model Number: PULSE
• Device Catalogue Number: EIPW22
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/27/2021
• Initial Report FDA Received Date: 08/25/2021
• 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: Death