MAUDE Adverse Event Report: SUNRISE MEDICAL (US) LLC QUICKIE QM710; WHEELCHAIR, POWERED

Model Number EIPW11

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Injury (2348)

Event Date 06/05/2015

Event Type  Injury  

Manufacturer Narrative

Sunrise medical's legal team is currently investigating this claim.Investigation into this allegation shows that a replacement suspension spring kit was requested on 6/8/2015.Associated service record (dated (b)(6) 2015) reports that the gas struts were replaced.Replacement gas struts were requested by national seating and mobility on 6/8/2015.No report of injury was made at that time or subsequent to that time.There were no other service-related parts orders, service requests, or complaints reported between 6/5/2015 and (b)(6) 2018 (the date of receipt of claimant's case (b)(4)).Sunrise has not been able to determine the root cause since this incident and alleged injuries have never been reported to sunrise medical (us) llc.An email communication received on (b)(6) 2018 from (b)(6) of (b)(6) included an attachment of an amended complaint, case (b)(4), whereby the claimant ((b)(6)) filed a claim of injury against (b)(6).This is the first claim of alleged injuries received by sunrise medical (us) llc and does not detail what injuries may have occurred.Therefore, root cause analysis cannot be performed at this time until additional details are provided by claimant.

Event Description

On 3/11/2018 sunrise medical (us) llc received notification from dealer, (b)(6), that his patient ((b)(6)) has filed a lawsuit for injuries.The amended complaint states (in paragraph 7) "a defective seatbelt and front wheels that do not touch the ground, causing the plaintiff to be injured." paragraph no.8 in the amended complaint states that "plaintiff, (b)(6), suffered injuries and damages of a personal, pecuniary and permanent nature.".

• Brand Name: QUICKIE QM710
• Type of Device: WHEELCHAIR, POWERED
• 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: 7393893
• MDR Text Key: 104226628
• Report Number: 2937137-2018-00003
• Device Sequence Number: 1
• Product Code: ITI
• UDI-Device Identifier: 05022408052363
• UDI-Public: 05022408052363
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083249
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: EIPW11
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/11/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/13/2014
• 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): Disability
• Patient Weight: 107