MAUDE Adverse Event Report: KI MOBILITY KI MOBILITY; FOCUS CRE

Model Number N/A

Device Problems Bent (1059); Break (1069)

Patient Problems Fall (1848); Head Injury (1879)

Event Date 04/16/2016

Event Type  malfunction  

Event Description

Customer claims that the user's wife had him outside and was pulling his chair backwards up a little ramp and when she set it down on the casters, one of them completely broke/bent under the chair.User fell out of the chair and hit his head on the concrete.This occurred when 1 caster broke/bent when chair was set back down on them.This happened on (b)(6) 2016 outside of the users facility.

• Brand Name: KI MOBILITY
• Type of Device: FOCUS CRE
• Manufacturer (Section D): KI MOBILITY; 5201 woodward ave; stevens point WI 54481
• Manufacturer (Section G): KI MOBILITY; 5201 woodward ave; stevens point WI 54481
• Manufacturer Contact: douglas munsey ; 5201 woodward ave; stevens point, WI 54481 ; 7152540992
• MDR Report Key: 5673856
• MDR Text Key: 46862273
• Report Number: 3005905321-2016-01923
• Device Sequence Number: 1
• Product Code: IOR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physical Therapist
• Type of Report: Initial
• Report Date: 05/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/25/2016
• Initial Date FDA Received: 05/23/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 40 YR