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

Model Number EIR4

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

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

Event Date 10/31/2014

Event Type  Injury  

Event Description

An adverse event that occurred on (b)(6) 2014 was reported to sunrise medical on (b)(6) 2015.It was reported that the end-user was sitting in his wheelchair and was reaching for something when he suddenly fell forward out of his wheelchair and onto the floor.As a result the end-user sustained a broken left tibia.

Manufacturer Narrative

The wheelchair involved in this adverse event did not malfunction in any way.This investigation is considered closed.There will be no supplement mdr filed to the fda.

• Brand Name: QUICKIE Q7
• Type of Device: WHEELCHAIR, MECHANICAL
• Manufacturer (Section D): SUNRISE MEDICAL (US) LLC; fresno CA 93727
• Manufacturer Contact: jeremy ybarra ; 2842 business park ave.; fresno, CA 93727 ; 5592942840
• MDR Report Key: 4493948
• MDR Text Key: 5345915
• Report Number: 2937137-2015-00002
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2015
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2014
• 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): Required Intervention
• Patient Age: 61 YR
• Patient Weight: 84