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

Model Number QUICKIE PULSE

Device Problem Insufficient Information (3190)

Patient Problem Full thickness (Third Degree) Burn (2696)

Event Date 02/06/2022

Event Type  Death  

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 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
• Type of Device: 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
• MDR Text Key: 287519378
• Report Number: 2937137-2022-00005
• Device Sequence Number: 1
• Product Code: ITI
• UDI-Device Identifier: 00016958051971
• UDI-Public: (01)00016958051971
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083249
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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
• Device Operator: Lay User/Patient
• Device Model Number: QUICKIE PULSE
• Device Catalogue Number: EIPW22
• Initial Date Manufacturer Received: 02/18/2022
• Initial Date FDA Received: 03/20/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/14/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 23 YR
• Patient Sex: Male