MAUDE Adverse Event Report: SUNRISE MEDICAL (US) LLC QUICKIE 2 LITE; MANUAL WHEELCHAIR

Model Number EIQ2N

Device Problems Break (1069); Loose or Intermittent Connection (1371)

Patient Problem No Code Available (3191)

Event Date 10/22/2015

Event Type  malfunction  

Manufacturer Narrative

Sunrise medical received damaged parts and an evaluation was completed by a quality investigator on 12/4/2015.The following results were found: the splines appear to be damaged.The housing bolts are loose and it may be the cause of the casters coming off.Cannot confirm if the failure was a maintenance issue or not.Will accommodate parts under warranty.Replacement parts shipped on 11/12/2015.This electronic mdr is being submitted to fda following a retrospective review of complaints conducted by sunrise medical, inc.As part of a corrective and preventive action discussed with fda in response to an inspectional observation.The review required a documented reassessment of each complaint for reportability under 21 cfr part 803.As a result of the assessment, this event was identified as meeting the regulatory reporting criteria in the company's current mdr procedure, and is being submitted to fda out of an abundance of caution and compliance to aid in providing fda with up-to-date information.

Event Description

Per dealer, (b)(6), caster housing fell apart when user was in the wheelchair and bumped his head.No treatment needed per dealer.User is in a nursing facility on carpet and hardwood floors.Per dealer both caster housings keep coming loose.

• Brand Name: QUICKIE 2 LITE
• 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: 6902365
• MDR Text Key: 89429554
• Report Number: 2937137-2017-00029
• 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: Other
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 10/22/2015

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: EIQ2N
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/22/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/26/2015
• 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 Weight: 109