MAUDE Adverse Event Report: SUNRISE MEDICAL (US) LLC QUICKIE Q700M; WHEELCHAIR, POWERED

Model Number	Q700M
Medical Device Problem Code	Device Difficult to Maintain (3134)
Health Effect - Clinical Codes	Fall (1848); Laceration(s) (1946); Unspecified Eye / Vision Problem (4471)
Date of Event	04/12/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The end user's spouse reports that the positioning belt for the wheelchair broke and while traveling down a slight ramp, the patient allegedly fell forward and sustained a black eye and a laceration above the eyebrow that required stitches.The end user had an x-ray and ct scan done which reportedly confirmed no broken bones or anything unusual.The right side of the positioning belt was previously detached and the left side had fraying, but was not broken.The spouse reports that they are currently using a gait belt to secure the end user in his wheelchair.
Additional Manufacturer Narrative
Background: quickie q700m owner's manual, page 27, section 8.1 states: "if a broken or loose component is found, discontinue use immediately and contact your sunrise medical authorized dealer for replacement." quickie q700m owner's manual, page 28 states: "check all straps for fraying, ripped seams or other indications of excessive wear damage.Discontinue use if damage is found and contact a sunrise medical authorized dealer." discussion: in reviewing the complaint, the end user's spouse reports that the positioning belt for the wheelchair broke and while traveling down a slight ramp, the patient allegedly fell forward onto the ground.The end user allegedly sustained a black eye and a laceration above the eyebrow that required stitches.The patient was taken to the emergency room where medical personnel reportedly ordered an x-ray and a ct scan, and there were no broken bones or anything noted to be out of the ordinary.There were reports of some bleeding through the stitches, but the nurses were able to stop it and no continuous treatment was required.The root cause of the event is possibly related to maintenance of the device.The end user's spouse reports that the right side of the belt came off by itself before the event occurred.There is also notable wear on the left side of the belt.According to the quickie q700m owner's manual, if a broken or loose component is found, the end user should discontinue the use of the device and contact a sunrise medical authorized dealer.The end user is currently using a gait belt in place of the positioning belt that came with the wheelchair.The spouse reports that she is currently working on contacting a dealer to order a replacement belt.Conclusion: due to the evidence of user malfunction related to wheelchair maintenance and the serious injury reported (a laceration requiring stiches), out of an abundance of caution, an mdr is being filed.

• Brand Name: QUICKIE Q700M
• Common Device Name: WHEELCHAIR, POWERED
• Manufacturer (Section D): SUNRISE MEDICAL (US) LLC; 2842 n business park avenue; fresno CA 93727 1328
• Manufacturer (Section G): SUNRISE MEDICAL (US) LLC; 2842 n business park avenue; fresno CA 93727 1328
• Manufacturer Contact: christian stephens ; 2842 n business park ave; fresno, CA 93727 ; 5592942374
• MDR Report Key: 14399381
• Report Number: 2937137-2022-00008
• Device Sequence Number: 12125390
• Product Code: ITI
• UDI-Device Identifier: 00016958059793
• UDI-Public: (01)00016958059793
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K172384
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/13/2022

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: Q700M
• Device Catalogue Number: EIPW25
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/15/2022
• Initial Report FDA Received Date: 05/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 81 YR
• Patient Sex: Male
• Patient Weight: 75 KG