MAUDE Adverse Event Report: SUNRISE MEDICAL (US) LLC QUICKIE Q400M; POWER WHEELCHAIR

Model Number	Q400M
Medical Device Problem Codes	Unintended Movement (3026); Noise, Audible (3273)
Health Effect - Clinical Code	Multiple Fractures (4519)
Date of Event	06/07/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Discussion: in reviewing the complaint, the dealer reports that the end user was driving in a straight direction at their senior facility center when the chair suddenly veered to the left, causing the chair to crash into a rail.It was reported that there was no outside elements or influential environmental factors that caused the incident.Based on the information provided, potential root causes for the chair veering into the rail could be either deterioration of the drive system caused by motor failure or brake failure or input device damage leading to unintended motion.The dealer reports that the end user allegedly sustained a broken ankle on one side and broken toes on the opposite foot during the event.The dealer was unable to provide the end user's contact information and did not have further details on what side each alleged injury occurred on, what treatment was provided or if any follow up appointments were necessary.Conclusion: while potential root causes indicate a malfunction occurred, the potential malfunctions typically would not result in serious injury or death if it were to recur; however, in this instance, a serious injury was reported (broken bones), so out of an abundance of caution, an mdr is being filed.
Event or Problem Description
Dealer reports that the end user was driving in their senior facility center when the chair veered to the left, causing the chair to crash into a rail, leading to the end user allegedly sustaining a broken ankle on one side and broken toes on the opposite foot.The dealer did not have specific details regarding the reported injury or any follow up treatment.The dealer also claims that afterwards, the chair was making a very loud grinding noise while moving certain directions.There was reportedly no outside element that caused the incident.

• Brand Name: QUICKIE Q400M
• 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: 15153209
• Report Number: 2937137-2022-00010
• Device Sequence Number: 12162875
• Product Code: ITI
• UDI-Device Identifier: 00016958059823
• UDI-Public: (01)00016958059823
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/02/2022

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: Q400M
• Device Catalogue Number: EIPW30
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/06/2022
• Initial Report FDA Received Date: 08/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/22/2022
• 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 Sex: Female
• Patient Weight: 98 KG