MAUDE Adverse Event Report: SUNRISE MEDICAL (US) LLC SWITCH-IT; WHEELCHAIR ACCESSORIES

Model Number DUAL PRO HEAD ARRAY

Device Problem Unintended Movement (3026)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/14/2021

Event Type  malfunction  

Manufacturer Narrative

Background information: age of device at time of complaint = 2 years 2 months.Expected lifetime of device is 5 years.Switch-it dual pro owner manual (247749, rev c., page 3) states: "warning! this device can be affected by electro-magnetic interference (emi) and radio frequency interference (rfi).Radio wave sources, such as radio stations, tv stations, amateur radio (ham) transmitters, two-way radios, and cellular phones can affect powered control.If unintended movement or brake release occurs, turn the power wheelchair off and do not operate until inspected, repaired, and/or replaced.If the chair acts in an erratic manner, turn the power wheelchair off and do not operate until inspected, repaired, and/or replaced.If the joystick stem is damaged, it can cause the chair to operate erratically, turn the power wheelchair off and do not operate until inspected, repaired, and/or replaced.If any of the device cabling becomes frayed, cut, or disconnected in any way, turn the power off and do not operate until inspected, repaired, and/or replaced." ufmea switch it master identifies the following risks: risk ids 1.6 and 1.7 are ranked the same for emi and rfi, respectively: occurrence = 2: highly improbable, severity = 3: serious, detectability = 3: low, (calculated risk score (rpn) = 18: "corrective action must be undertaken to make the risk as low as reasonably practicable through design or risk/benefit analysis must be performed and documented.Risk/benefit rationale states "the risk of electromagnetic interference causing issues in the operation of the device has been mitigated to the lowest level possible during the design process and each applicable device has been validated through the emc tested done on each product, which tested said products to these standards: iec 60601-1-2: 2007; cispr 11: 2009, a1: 2010, iso 7176-21: 2003; iso 7176-14: 2008; en 12184: 2010.The occurrence rate is scored low (2) on the basis of the design and testing of the devices.The design of each device was done to ensure that the device was insulated from electromagnetic interference, through component selection and circuit board design.Each device was then tested to the emc interference standards, which includes testing the susceptibility of the device to electromagnetic interference.The risk of said interference cannot be fully eliminated, but the devices have been tested to the required standards.The severity is scored as moderate (3) injury due to the possibility of accidents from unintended wheelchair operation.Electromagnetic interference could cause any form of unintended driving of the wheelchair, which does expose the user to the risk of collision at this level of severity.The detectability of this risk has been scored as possible to intervene (3) as the unintended driving behavior from electromagnetic interference could be detected as the wheelchair enters the range of interference and the wheelchair could then be removed from the range before the chair begins to drive.This failure could be avoided through knowledge gained from the owner's manual related to interference possibility.Any further mitigation of this risk may affect appropriate operation of the device or could reduce the benefits of the device's operation on the wheelchair." discussion: end user / caregiver reports unintended motion from this power wheelchair (unspecified) using a switch-it dual pro head array controller.There are no details provided by the end user / caregiver on what unintended motions occurred.It is not clear as to whether the complainant is an end user or the caregiver of the end user.Unintended motion is a known issue that can result in a malfunction leading to potential for serious injury.In this case, no injury was reported.Likelihood of serious injury is ranked as highly improbable and no serious injuries on this product line have been reported to sunrise medical from unintended motion malfunctions.Since no details around the malfunction were reported, it is impossible to determine root cause of the malfunction.The dual pro is expected to be returned to the manufacturer for inspection and testing.Once that head array is returned and inspection and testing complete, a supplemental report will be filed with those findings.Conclusion: this mdr is being filed due to the potential for a serious injury were the malfunction to recur.Supplemental report will be filed once the product is returned and inspection and testing is complete.

Event Description

Incident reported out of (b)(6): customer reported to sunrise representative via email the following: "there's a bracket that needs replaced on it and a general overhaul, mum reported that it was activating and driving on its own".No report of injury.No description of what bracket needs replacing or why.

Manufacturer Narrative

Background information: switch-it dual pro owner manual ((b)(4), rev c) states: "[i]n case of damage, do not use." the policy also states that "[i]f the chair acts in an erratic manner, turn the power wheelchair off and do not operate until inspected, repaired, and/or replaced." discussion: end user / caregiver reports unintended motion from the power wheelchair (unspecified) using a switch-it dual pro head array controller.There are no details provided by the end user / caregiver on what unintended motions occurred.It is not clear as to whether the complainant is an end user or the caregiver of the end user.The returned device was evaluated.User caused damage was noted on the db9 cable, left side usb connector, back bracket, and swing arms.No unintended motion was replicated upon evaluation.Based on the condition of the returned unit, failure of the device is attributed to accidental mechanical damage which is a use error.Conclusion: use error is the most probable cause of the original complaint.The product in question met all product specifications before release for distribution at the time of shipping to the customer.This device is used for treatment, not diagnosis.This is most likely not a malfunction and is not likely to result in serious injury or death if it were to recur.

Event Description

Incident reported out of (b)(6): customer reported to sunrise representative via email the following: "there's a bracket that needs replaced on it and a general overhaul, mum reported that it was activating and driving on its own".No report of injury.No description of what bracket needs replacing or why.

• Brand Name: SWITCH-IT
• Type of Device: WHEELCHAIR ACCESSORIES
• 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: 12631913
• MDR Text Key: 284383770
• Report Number: 2937137-2021-00046
• Device Sequence Number: 1
• Product Code: KNO
• UDI-Device Identifier: 00016958058420
• UDI-Public: 00016958058420
• Combination Product (y/n): N
• Reporter Country Code: EI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DUAL PRO HEAD ARRAY
• Device Catalogue Number: DPP-WH-CON
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/14/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/11/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1