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

Model Number	QUICKIE IRIS
Medical Device Problem Codes	Retraction Problem (1536); Unintended Movement (3026)
Health Effect - Clinical Codes	Neck Stiffness (2434); Unspecified Respiratory Problem (4464); Cramp(s) /Muscle Spasm(s) (4521)
Date of Event	08/30/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Dealer reports that when the wheelchair is in recline, the right piston is not holding in place, causing the chair to gradually lean more to the right side.The caregiver reports that the lean and the continued use of the wheelchair despite the lean has allegedly led to the rider experiencing a stiff neck, contractures and an excessive buildup of secretions that reportedly requires more breathing treatments/assistance coughing.Also, the caregiver reports new pressure points are allegedly forming.No pressure sores are reported.
Additional Manufacturer Narrative
Background information: quickie & zippie iris owner's manual, rev d, states: "1.Proper maintenance will improve performance and extend the useful life of your chair 3.If discovered, repair or replace loose, worn, bent or damaged parts before using the chair.5.Inspect and maintain this chair strictly per the maintenance chart.6.If you detect a problem, make sure to order parts, or have service, and repair work done at your authorized dealer before use." ufmea_manual tilt wheelchairs_master document was reviewed and the most likely risk id based on the information available was determined to be: risk id 44: function- loss or deterioration of function: recline mechanism.Specifically, the gas spring cylinder lost function.Recline stuck- user stranded or unable to position.Discussion: dealer reports that when the chair is in recline, the right piston is not holding in place, causing the chair to gradually lean more to the right side.The potential root cause could possibly be related to loss or deterioration of function of the recline mechanism, specifically the gas spring cylinders.A decline in functionality of the recline mechanism could potentially lead to the user being unable to place themselves in ideal positioning for their medical requirements.The most probable resultant failure mode is that the cable for the recline system became misaligned.This misalignment would cause the recline system to activate and the piston (cylinder) to not hold its position and be able to move.This potential root cause has not been fully evaluated because the wheelchair has not been returned for further evaluation and the repair has not yet been completed.As stated in the owner's manual, when a problem is detected, repair work should be completed before using the device again.Sunrise medical does not recommend continuous use of a chair that needs to be repaired.The caregiver is currently waiting on the dealer to receive the parts needed to complete the repair but is still using the chair in the meantime.The caregiver reports that the lean and continued use despite the need for repair has allegedly led to a worsening in the end user's medical condition.Allegedly, the rider has been experiencing a stiff neck, contractures and an excessive buildup of secretions that reportedly requires more breathing treatments/assistance coughing.Also, the caregiver reports new pressure points are allegedly forming due to the lean.No pressure sores have been reported conclusion: this can only be a preliminary analysis because the wheelchair has not been returned to sunrise medical and the dealer has not yet completed any repair.Regardless, because of the alleged worsening of the end user's condition and the medical interventions alleged to be necessary (breathing treatments, assistance with coughing), an mdr is being filed out of an abundance of caution.

• Brand Name: QUICKIE IRIS
• Common Device Name: MANUAL WHEELCHAIR
• 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: 15514599
• Report Number: 9616084-2022-00017
• Device Sequence Number: 17436084
• Product Code: IOR
• UDI-Device Identifier: 00016958046861
• UDI-Public: (01)00016958046861
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/29/2022

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: QUICKIE IRIS
• Device Catalogue Number: EIZ4-2
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/30/2022
• Initial Report FDA Received Date: 09/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/08/2022
• 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; Required Intervention
• Patient Age: 19 YR
• Patient Sex: Male
• Patient Weight: 49 KG