MAUDE Adverse Event Report: SUNRISE MEDICAL LLC QUICKIE; POWERED WHEELCHAIR

Model Number QUICKIE Q300M

Device Problems Component Missing (2306); Device Misassembled During Manufacturing /Shipping (2912)

Patient Problems Headache (1880); Visual Impairment (2138); Numbness (2415); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/10/2023

Event Type  Injury  

Manufacturer Narrative

Discussion: in reviewing the complaint, the end user's physical therapist reports that while the end user was out with his wife, he began to reverse his wheelchair off the vehicle lift when the back collapsed halfway down, leading to the end user falling backwards within the wheelchair.The wheelchair back was "floppy" and would not come back up after the incident.The end user's wife noticed a screw/pin from the piston on the ground near the wheelchair.It was also reported that there were no "c-clamps" in place on the remaining bolt on the back of the wheelchair.The end user reports that the back pins were never touched and the back had not been folded since he received the wheelchair.Based on the information provided, the most probable cause would be the clips that would normally hold the pins in place located in the rear gas strut were not mounted as intended.It was communicated and agreed that the end user should not use the wheelchair until it is fully repaired.After the incident, the end user reports the fall backwards felt like whiplash.Initially, the end user went home to rest and take some medication.X-rays were ordered for the end user's back and neck area but there were no abnormal results found.The end user reports symptoms such as radiating pain, tingling/numbness and trouble focusing in his left eye.There has been no formal diagnosis communicated.Conclusion: in conclusion, the gas strut on the wheelchair back manual recline was likely not mounted correctly with the required hardware.This device is used for treatment, not diagnosis.Due to the allegation of symptoms that indicates a potential serious injury, this mdr is being filed.Additional note: the original mdr was submitted on 11/17/2023 within the 30-day requirement defined in 21 cfr 803 with a successful acknowledgement 1 and 2, however it was identified that acknowledgement 3 indicated that the submission failed and was not entered in the cdrh database.It was found that the cause of this failure was attributed to an error in the manufacturer number and a lack of clear guidance for verifying successful submission in the organization's procedures.Corrective actions have been implemented correcting the manufacturer number in the organization's procedures and defining the steps required to verify successful entry into the cdrh database.While the original submission was on-time, this filing is being made because the original submission was not successfully entered into the cdrh database within the 30-day submission requirement.

Event Description

The end user's physical therapist reports that while the end user was out with his wife, the wheelchair back collapsed halfway down, leading to the end user falling backwards in the wheelchair.While there has been no formal diagnosis communicated, the end user reports symptoms such as radiating pain, tingling/numbness and trouble focusing in his left eye.The end user has stopped using the wheelchair until it is fully repaired.

• Brand Name: QUICKIE
• Type of Device: POWERED WHEELCHAIR
• Manufacturer (Section D): SUNRISE MEDICAL LLC; 12002 volunteer blvd; mount juliet TN 37122
• Manufacturer (Section G): SUNRISE MEDICAL LLC; 12002 volunteer blvd; mount juliet TN 37122
• Manufacturer Contact: christian stephens ; 12002 volunteer blvd; mount juliet, TN 37122 ; 2708475823
• MDR Report Key: 18226742
• MDR Text Key: 329238435
• Report Number: 3019677893-2023-00004
• Device Sequence Number: 1
• Product Code: ITI
• UDI-Device Identifier: 00016958060485
• UDI-Public: 00016958060485
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172384
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: QUICKIE Q300M
• Device Catalogue Number: EIPW40
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/19/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/12/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 100 KG