MAUDE Adverse Event Report: SUNRISE MEDICAL (US) LLC QUICKIE PULSE; POWER WHEELCHAIR

Model Number EIPW22

Device Problem Misassembly by Users (3133)

Patient Problem Limb Fracture (4518)

Event Date 01/02/2021

Event Type  Injury  

Manufacturer Narrative

Background information: the quickie pulse owner manual (document number 119832, revision h, page 7) states: "warning! never use non-quickie parts to replace quickie provided parts or make changes to your chair unless authorized by sunrise.(doing so will void the warranty and may create a safety hazard.)" page 30 of the owner manual states: "a.Dealer service introduction: 3.All major maintenance and repair work should be done by the authorized dealer." manufacturer's investigation: the end user claimed, during a phone call, that the chair, operated on its own on numerous occasions.On this occasion, when the injury occurred, the end user was driven into a wall that resulted in a fractured femur.Preliminary root cause analysis was performed and the cause could not be determined.Therefore, the chair was requested back by sunrise medical so the chair could be evaluated by the quality team.Failure analysis report: 01/29/21 14:59:44 boykog: clients pulse 6 chair (s/n (b)(4)) was returned to assessment jan-21-2021.It was thoroughly cleaned prior to inspection.It was observed that the joystick harness and mono switch installed on the chair by a third-party dealer to operate the seat lift, showed evidence of being altered with non-oem parts.It is expected that a short was also present with the mono switch.A review of the ufmea was conducted.Risk id 147: unintended movement, risk id 473: specification of service and maintenance; unintended movement / forward impact to an object: user's feet or legs impact object with this condition.The switch had evidence of black electrical tape and the harness was unshielded with some remaining shielding broken and spliced to other wires also with electrical tape.When the chair was power up the seat elevate function operated upwards without pressing the switch.The hardware to secure the chair in place for the seat lift to base had cut wires screwed into the side of lift.All unsanctioned parts were removed and only approved sunrise medical oem components installed and routed correctly.This included a lanyard kit for hardware, a mono switch and joystick harness.The control module was also replaced.The unit was powered up and fully tested through all functions.It was determined the unit operated as intended with no recurrence of the issue.The control module was reprogrammed and verified.No evidence was found after the removal of the non-oem parts that risk id 147, 473 was retained.Additional information: the initial purchase of the chair did not include functionality for the lift or tilt functionality.The initial purchase of the quickie pulse wheelchair only included a simple positional, hand-operated joystick that permitted forward, backward, and turning functions.No additional functions were purchased at that time.Upon user request, a non-authorized dealer, added a separate switch to operate the lift and tilt functions of the quickie pulse wheelchair.It is unknown which dealer or at what time this modification occurred.This modification was unsanctioned and was not done in a manner consistent with sunrise medical practices or requirements.All unsanctioned modifications actually void user warranties.Conclusion: the quickie pulse wheelchair was tampered with and this tampering resulted in the chair "driving by itself" and causing the injury.The quickie pulse wheelchair, after being evaluated by sunrise was returned to factory specifications with the addition of appropriate equipment to operate the lift function of the wheelchair using sunrise authorized oem parts.Testing demonstrated that the chair performed as intended and the chair was returned to the user.It is assumed that the end user will still undergo future medical treatment for her fractured femur.If additional information is received about the patient's injuries, a supplemental report will be filed at that time, if needed; otherwise, sunrise medical considers this matter closed.

Event Description

While in use, the end user's power wheelchair ran her into a wall while allegedly "driving on its own".The result was a cut on the knee and a fractured femur (confirmed by x-ray) that required medical intervention (casting).Two-week follow-up shows the fracture was "healing well" according to medical provider.See additional manufacturer's narrative for root cause analysis and full details.

• Brand Name: QUICKIE PULSE
• Type of Device: POWER WHEELCHAIR
• Manufacturer (Section D): SUNRISE MEDICAL (US) LLC; 2842 n business park ave; fresno CA 93702 1328
• Manufacturer (Section G): SUNRISE MEDICAL (US) LLC; 2842 n business park ave; fresno CA 93702 1328
• Manufacturer Contact: devin mcelroy ; 2842 n business park ave; fresno, CA 93702-1328 ; 5592942374
• MDR Report Key: 11282796
• MDR Text Key: 230459882
• Report Number: 2937137-2021-00001
• Device Sequence Number: 1
• Product Code: ITI
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K083249
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: EIPW22
• Device Catalogue Number: EIPW22
• Date Manufacturer Received: 01/08/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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): Other
• Patient Age: 75 YR
• Patient Weight: 50