MAUDE Adverse Event Report: SUNRISE MEDICAL (US) LLC QUICKIE 2; MANUAL WHEELCHAIR

Model Number EIQ2N

Device Problem Device Tipped Over (2589)

Patient Problem Fall (1848)

Event Date 08/21/2015

Event Type  Injury  

Manufacturer Narrative

Sunrise medical received the damaged rear frame and was evaluated by a quality inspector on (b)(6) 2015.The following was found: the back frame broke on the upright tube through the top hole.This hole is reserved for chairs manufactured with the angle adjustable backrest.I verified this chair was not configured with this option.Someone has modified the chair from its original configuration, resulting in the failure to the back frame.The frame components were replaced under warranty as an accommodation.Both the right and left rear side frames were ordered and shipped on 8/24/2015.This electronic mdr is being submitted to fda following a retrospective review of complaints conducted by sunrise medical, inc.As part of a corrective and preventive action discussed with fda in response to an inspectional observation.The review required a documented reassessment of each complaint for reportability under 21 cfr part 803.As a result of the assessment, this event was identified as meeting the regulatory reporting criteria in the company's current mdr procedure, and is being submitted to fda out of an abundance of caution and compliance to aid in providing fda with up-to-date information.

Event Description

Per dealer, (b)(5), stated the end user was doing a pressure relief (repositioning on chair).The chair fell over backwards and the patient hit his head on the floor.An ambulance came and put him in bed.The dealer also stated the rear side frame is broken on the right side, at the top where the back cane goes in.

• Brand Name: QUICKIE 2
• 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: 6901421
• MDR Text Key: 87654973
• Report Number: 2937137-2017-00026
• Device Sequence Number: 1
• Product Code: IOR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K973673
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 08/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: EIQ2N
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/21/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/09/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Weight: 107