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

Model Number	QUICKIE PULSE
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Full thickness (Third Degree) Burn (2696)
Date of Event	02/06/2022
Type of Reportable Event	Death
Additional Manufacturer Narrative
Discussion: due to limited information, no root cause has been established.The investigative field incident report generally referred to an appearance of electrical malfunction in the powered wheelchair but did not provide detail.There is no confirmation on where the fire started or what was the cause.Investigation by the fire marshal is still in progress.Dealer reported that it had replaced the batteries on the wheelchair in november 2021 and had serviced the power module for the wheelchair in the weeks prior to the incident, but the extent of that service and whether any repair occurred is not known at this time.There has been no communication on official cause of death.No additional information has been provided outside of the initial report and patient condition update.Conclusion: due to the nature of this injury (death), this mdr is being reported out of an abundance of caution.Should new information be received, a supplemental report will be filed.
Event or Problem Description
Dealer was informed that the end users chair was involved in a fire on (b)(6) 2022.It was reported that the end user suffered third degree burns.The end user passed away on (b)(6) 2022.A fire department field incident report was provided by an attorney representing the beneficiaries of the end user which was received by mail on march 17, 2022.The report provides that the incident is still under investigation by the fire marshal.

• 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: 13834780
• Report Number: 2937137-2022-00005
• Device Sequence Number: 19183399
• Product Code: ITI
• UDI-Device Identifier: 00016958051971
• UDI-Public: (01)00016958051971
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 03/18/2022

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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/18/2022
• Initial Report FDA Received Date: 03/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/14/2016
• 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: Death
• Patient Age: 23 YR
• Patient Sex: Male