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

Model Number EIPW11

Device Problems Break (1069); Detachment Of Device Component (1104); Component Falling (1105); Crack (1135); Noise, Audible (3273)

Patient Problem Fall (1848)

Event Date 08/29/2017

Event Type  malfunction  

Manufacturer Narrative

Sunrise medical has requested from the dealer the return of the damaged parts for a full evaluation.It cannot be determined at this point if a malfunction has occurred or if the product is defective.Upon receiving the damaged item(s) an evaluation will be performed and a supplemental report will be filed with any relevant findings.

Event Description

Per dealer technician the housing that attaches the recline actuator to the recline-back framing has cracked and broken.User claims he reclined back and when tried to recline back up to the home position, he heard a pop / snap sound and the back fell off.He fell back out of the chair, but wasn't hurt.Recline will not operate correctly.

• 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: 6892659
• MDR Text Key: 88254829
• Report Number: 2937137-2017-00023
• 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: Service Personnel
• Type of Report: Initial
• Report Date: 08/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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: 08/29/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/15/2017
• 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: 136