MAUDE Adverse Event Report: SUNRISE MEDICAL TECHNOLGIAS S.A. DE CV QUICKIE QXI; WHEELCHAIR, MECHANICAL

Model Number EIF6

Device Problems Loose or Intermittent Connection (1371); Device Tipped Over (2589)

Patient Problems Fall (1848); Injury (2348)

Event Date 03/25/2015

Event Type  Injury  

Event Description

An adverse event involving a quickie qxi wheelchair was reported to sunrise medical on (b)(6) 2015.The dealer stated the left front caster stem bolts came loose causing the wheelchair to tip over.As a result the end-user fell out of his wheelchair and sustained a broken ankle.The dealer claims the event occurred during normal use of the device.

Manufacturer Narrative

It appears the wheelchair and/or parts involved in this incident are being returned to sunrise medical.If and when the chair/parts are received, our internal failure investigator will complete the investigation and a follow up will be filled.

• Brand Name: QUICKIE QXI
• Type of Device: WHEELCHAIR, MECHANICAL
• Manufacturer (Section D): SUNRISE MEDICAL TECHNOLGIAS S.A. DE CV; privada misions #110; pargue inducatrial misiones; tijuana, b.c. 2242 5; MX 22425
• Manufacturer Contact: jeremy ybarra ; 2842 business park ave; fresno, CA 93727 ; 5592942840
• MDR Report Key: 4723733
• MDR Text Key: 19406225
• Report Number: 9616084-2015-00002
• Device Sequence Number: 1
• Product Code: IOR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 03/25/2015

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: EIF6
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/25/2015
• Initial Date FDA Received: 04/20/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/05/2014
• 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: 54 YR
• Patient Weight: 111