MAUDE Adverse Event Report: SUNRISE MEDICAL (US) LLC QUICKIE QM710; POWERED WHEELCHAIR

Model Number	QM710
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/01/2021
Type of Reportable Event	Death
Additional Manufacturer Narrative
Discussion: the wheelchair software fault log was assessed (see attached report for details).Causality could not be determined.Subject wheelchair has not yet been evaluated by sunrise and is being held by legal authorities.At the current time, it is unknown whether the chair malfunctioned or operated as intended.The fault log does not demonstrate any faults that could have led to a malfunction in chair operations or a tip over event.Conclusion: due to nature of injury (death), this mdr is being reported out of an abundance of caution.However, no malfunction has yet been identified.Investigation is pending results of coroner investigation.Once new information is received, a supplemental report will be filed.
Event or Problem Description
Sunrise dealer in (b)(6) "informed us that a user was traveling up a ramp in a quickie qm710 and resulted in death." incident is currently being investigated by the coroner.No other information was provided.Fault log was provided by coroner and assessment of controller log is attached.

• Brand Name: QUICKIE QM710
• Common Device Name: POWERED WHEELCHAIR
• Manufacturer (Section D): SUNRISE MEDICAL (US) LLC; 2842 n business park ave; fresno CA 93727
• MDR Report Key: 12394347
• Report Number: 2937137-2021-00043
• Device Sequence Number: 4724186
• Product Code: ITI
• UDI-Device Identifier: 00016958052367
• UDI-Public: (01)00016958052367
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K060531
• 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): 08/31/2021

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: Lay User/Patient
• Device Model Number: QM710
• Device Catalogue Number: EIPW11
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/11/2021
• Initial Report FDA Received Date: 08/31/2021
• 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