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

Model Number EIGPSA

Device Problems Detachment Of Device Component (1104); Component Falling (1105); Loose or Intermittent Connection (1371)

Patient Problems Fall (1848); Injury (2348)

Event Date 11/04/2015

Event Type  malfunction  

Manufacturer Narrative

On (b)(6) 2015 quality manager, (b)(6), contacted the end-user and she claims that the chair was given to her less than a year ago.She claims that the nuts backed off of the eccentric bolts on the caster housing.She stated that she has not done any preventative maintenance and she has not contacted the dealer to do any preventative maintenance on her chair.Dealer did not send the parts back to sunrise medical.Therefore, an evaluation was not performed and a root cause for the failure could not be determined.A quote was created for the replacement parts, however, the dealer never placed the order.The outcome of the chair is unknown.

Event Description

On (b)(6) 2015 per end user says she was pushing herself in the chair when the side of the caster and screw came loose and fell off, her chair fell sideways and she fell out and hurt her arm.End user doesn't know how bad her injury is and hasn't gone to the doctor yet.

• Brand Name: QUICKIE GPSA
• 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: 6902486
• MDR Text Key: 88931298
• Report Number: 2937137-2017-00030
• 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: Service Personnel
• Type of Report: Initial
• Report Date: 11/04/2015

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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: EIGPSA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/04/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/31/2014
• 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