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

Model Number EIR4

Device Problems Break (1069); Device Tipped Over (2589)

Patient Problems Muscle Spasm(s) (1966); Pain (1994); Weakness (2145); Brain Injury (2219); Loss of consciousness (2418); Spinal Cord Injury (2432)

Event Date 08/01/2016

Event Type  Injury  

Manufacturer Narrative

The subject wheelchair has been confirmed by sunrise medical (us) llc to have been affected by the voluntary recall initiated on 7/5/2016 by sunrise medical for the quickie q7 backrest brackets.This issue is addressed in capa (b)(4).In researching the history of this wheelchair, sunrise medical received notice on 1/25/2017 by way of an acknowledgement and response form via email from (b)(4) stating that the backrest brackets were replaced with the upgraded brackets and repairs were completed by (b)(4).On 1/11/2017.At the time of receiving this information or any time prior to (b)(4) repair notice, sunrise medical was not made aware of an adverse event involving a serious injury or malfunction of the product.The legal complaint received on may 15, 2018 is the first sunrise medical was made aware of an adverse event involving the subject wheelchair.Sunrise medical's legal department is currently addressing this complaint.

Event Description

A legal complaint notice was received by sunrise medical (us) llc on may 15, 2018 from the court of common pleas of (b)(6) stating the following allegation: in or about (b)(6) 2016, plaintiff was getting the mail at his home.When plaintiff was reaching for his mail, the backrest bracket of his quickie q7 wheelchair suddenly and without notice broke.This failure of the backrest bracket caused plaintiff's body to involuntarily fall backward in the chair, changing the center of balance.This immediately made plaintiff's wheelchair unstable and caused it to tip over backward, ejecting plaintiff from the chair.In the course of being thrown from the chair, plaintiff struck his head and upper spine on a concrete floor, knocking him unconscious.As a result of the fall, plaintiff was rushed to (b)(6) medical center by an emergency squad.Among plaintiff's numerous physical injuries are an acute brain injury, spinal cord injury, weakness and loss of function in his upper extremities, sustained and uncontrollable muscle spasms, and extreme/unremitting pain.

Event Description

This mdr filing is to correct the wheelchair serial number only.The wrong serial number was entered in the original mdr.See original mdr for more information on the incident.

Manufacturer Narrative

This mdr filing is to correct the wheelchair serial number from (b)(4) to (b)(4).Serial number (b)(4) is a replacement wheelchair for the end user.The adverse event occurred while the end user was using wheelchair (b)(4).A second correction is being made to the 510(k) number listed.The correct 510(k) number for this device is k973673.Thank you.

• Brand Name: QUICKIE Q7
• Type of Device: MANUAL WHEELCHAIR
• Manufacturer (Section D): SUNRISE MEDICAL (US) LLC; 2842 business park ave.; fresno CA 93727
• MDR Report Key: 7599356
• MDR Text Key: 111016395
• Report Number: 2937137-2018-00007
• Device Sequence Number: 1
• Product Code: IOR
• Combination Product (y/n): N
• PMA/PMN Number: K973673
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 09/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2018
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization