MAUDE Adverse Event Report: SUNRISE MEDICAL (US) LLC QUICKIE Q7; MANUAL WHEELCHAIR

Model Number EIR4

Device Problem Device Tipped Over (2589)

Patient Problems Fall (1848); Bone Fracture(s) (1870)

Event Date 12/06/2017

Event Type  Injury  

Manufacturer Narrative

Sunrise medical performed a service search and found that only one service parts request was made for this chair for replacement wheel locks and a footrest cover.These items were shipped to the dealer on 1/18/2019 and are not related to the alleged incident that occurred on (b)(6) 2017.No other complaints, including the 2017 incident were ever called in to sunrise medical.Since the summons provides no details of any possible failed parts, malfunctions or defects that may have caused or contributed to the chair tipping forward, combined with no history of replacement parts, sunrise medical is unable to determine the root cause for the alleged incident.However, two likely causes that could lead to a q7 or any wheelchair to tip forward would be due to an improper center of gravity setting or the chair was not properly sized by the dealer to fit the end user's needs and specifications.A malfunction or defect is not likely in this case, as it is stated on page 8, section e.Reaching or leaning, of the q7 owner's manual: "if you reach or lean, it will affect the center of balance of your chair.This may cause you to fall or tip over." again, since this is a legal case and the subject wheelchair was not released for inspection, sunrise medical is unable to perform a proper evaluation and determine the actual root cause for the chair tipping forward.Sunrise medical's legal team is currently addressing this claim.No further investigation will be performed by the ra/qa team at this time.If any new relevant information is provided a supplemental report will be filed.

Event Description

Sunrise medical received on 1/24/2019 a court summons from the law offices of (b)(6), (b)(6) 2019.The legal summons stated as follows: "on (b)(6) 2017, (plaintiff) was in his quickie 7 wheelchair at his home and when he ever so slightly leaned forward, the wheelchair tipped all the way forward causing (plaintiff) to fall out of his quickie 7 wheelchair resulting in a broken right leg, surgery and months of therapy." end statement.The name of the complainant was removed and replaced with "plaintiff" for the purposes of this report only.

• Brand Name: QUICKIE Q7
• Type of Device: MANUAL WHEELCHAIR
• Manufacturer (Section D): SUNRISE MEDICAL (US) LLC; 2842 business park ave.; fresno CA 93727
• Manufacturer (Section G): SUNRISE MEDICAL (US) LLC; 2842 business park ave.; fresno CA 93727
• Manufacturer Contact: gustavo zambrano ; 2842 business park ave.; fresno, CA 93727 ; 5592942840
• MDR Report Key: 8337981
• MDR Text Key: 136115758
• Report Number: 2937137-2019-00006
• Device Sequence Number: 1
• Product Code: IOR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123975
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: EIR4
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/24/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/14/2017
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention