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

Model Number EIR4

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fall (1848); Complaint, Ill-Defined (2331)

Event Date 08/29/2017

Event Type  malfunction  

Manufacturer Narrative

Sunrise medical customer service representative provided to the end user the contact information for (b)(6) medical in (b)(6).The end user confirmed to the customer service representative via email on (b)(6) 2017 that he did get in contact with (b)(6) medical and advised that the dealer will get in touch with us for repair parts.He did not give an update as to his condition or if he went to the hospital for treatment.At this time, sunrise medical has not been contacted by said dealer.The end user is currently in another chair.The issue with the frame breaking has been identified by the photos that were provided by the end user as to be the frame tubing having insufficient strength.This has been addressed in capa (b)(4).

Event Description

Received a call from end user, he stated that yesterday (b)(6) 2017 about 7 or 8 pm he came home from the hospital getting teeth work done and as soon as he got into his house he stated he heard a snap and he fell backwards out of his chair.He stated he had to call ems to come help him get up and into his old chair.He stated he is paralyzed and this morning when he woke up he is not feeling well and is going to have his worker look over him and see if he has any bruising and if so he will go to the hospital.

Manufacturer Narrative

Please note that serial number (b)(4) that was recorded in the initial mdr 2937137-2017-00024 is incorrect.The serial number should read (b)(4).

Event Description

This submission is to correct initial mdr 2937137-2017-00024, as the wheel chair serial number is incorrect.

• 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: 6892739
• MDR Text Key: 87738890
• Report Number: 2937137-2017-00024
• 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: Patient
• Type of Report: Initial,Followup
• Report Date: 10/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: EIR4
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/10/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/28/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Weight: 109