MAUDE Adverse Event Report: SUNRISE MEDICAL (US) LLC QUICKIE Q700M; WHEELCHAIR, POWERED

Model Number	Q700M
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Laceration(s) (1946)
Date of Event	04/03/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Background: quickie q700m owner's manual, page 8, section 3.1 states: "driving a powered wheelchair requires cognitive, physical, and visual skills.The user must be able to estimate and correct the results of actions when operating the wheelchair." quickie q700m owner's manual, page 17 states: "while driving this seating system in the reclined, elevated, or tilted position, use caution." discussion: in reviewing the complaint, the dealer reports that the end user allegedly sustained two separate injuries on two separate days.The first incident reportedly occurred on (b)(6) 2022.According to the end user, the chair tipped over while she was in it by the fridge in her kitchen.The end user reportedly has no memory of event and she allegedly blacked out and spent 4 hours on the floor before awakening and notifying ems.The end user initially refused to go to the hospital.The day after the event, the end user contacted ems again due to pain and was taken to the hospital where she was diagnosed with 3 fractured ribs.No further medical treatment was prescribed at the time.The second event reportedly occurred on (b)(6) 2022.The end user tilted backwards while approaching a table with metal legs and her left leg allegedly got caught on the table, producing a laceration that needed medical intervention.The end user allegedly did not have sensation in her legs and did not notice the injury until she saw blood steaming down her leg.The end user was taken to the hospital where she received 25 stitches.The patient remained in the hospital for 1-2 days and was released with no additional medical treatment required.By all accounts, the wheelchair seems to have performed as intended.There is limited information on what could have caused the first incident.The second incident seems to be caused by a use malfunction, where the end user was seemingly unable to correctly judge the distant between themselves and the table in their environment.According to the owner's manual, it is important that a user has cognitive, physical, and visual skills to operate a powered wheelchair and be able to estimate and correct the results of actions when operating the wheelchair to avoid serious injury.The dealer has recommended that the client be reassessed on her medical condition and whether the chair she is using is the right fit for her due to cognitive difficulties and memory issues.Conclusion: while there is no indication of the product malfunctioning, there is evidence of user malfunction and due to the serious injuries reported (fractured ribs and a laceration requiring stitches), out of an abundance of caution, an mdr is being filed.
Event or Problem Description
Dealer reports that the end user allegedly sustained two separate injuries on two separate days: chair seemingly tipped sideways with end user in it by the fridge in her apartment.The end user reportedly has no memory of how the incident occurred and received 3 fractured ribs during the event.The end user tilted backwards and her left leg allegedly caught the table she was approaching, producing a laceration that needed medical intervention, leading to the patient receiving 25 stitches.The dealer is recommending having the client reassessed on her medical condition and whether the chair she is using is the right fit due to cognitive and memory issues.Client is confined to user her wheelchair the entire day and continues to use the wheelchair in question to this day.

• Brand Name: QUICKIE Q700M
• Common Device Name: WHEELCHAIR, POWERED
• 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: 14379260
• Report Number: 2937137-2022-00007
• Device Sequence Number: 20467361
• Product Code: ITI
• UDI-Device Identifier: 00016958059793
• UDI-Public: (01)00016958059793
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K172384
• 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): 05/12/2022

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: Q700M
• Device Catalogue Number: EIPW25
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/13/2022
• Initial Report FDA Received Date: 05/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/10/2021
• 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: Other
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 102 KG