MAUDE Adverse Event Report: MAX MOBILITY LLC SMARTDRIVE

Model Number MX2+

Device Problems Self-Activation or Keying (1557); Activation, Positioning or Separation Problem (2906); Activation Problem (4042)

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

Event Date 06/08/2022

Event Type  malfunction  

Event Description

Permobil ab recevied report claiming the end-user was at a train station utilizing their panthera x wheelchair with a smartdrive unit attached.Reports claim the smartdrive unit engaged power drive without the end-user's command.The end-user could not turn it off via the switch control buttons, but by using the wheel brakes on the wheelchair succeeded to stop the chair.With help from the end-user's partner, they turned off the smartdrive unit at the main power switch.

Manufacturer Narrative

Reports claim the smartdrive unit engaged power drive without the end-user's command.The end-user could not turn it off via the switch control buttons, but by using the wheel brakes on the wheelchair, succeeded to stop the chair.No injuries were sustained as a result.Inspection of device was conducted by service provider who report having found a pinch in the cabling, for the switch control button, used to engage/disengage the smartdrive device.The pinching of the cable caused 2 of the internal wires to contact, completing a circuit, which sent a signal to the drive unit to engage drive motor.Permobil nor the dealer can establish a timeline as to when the initial damage to the cable occurred.The damaged switch control button assembly was replaced with new and smartdrive unit operated normally with no further recurring issues of involuntary engagement of drive command.Permobil concluded the cause for the unintended activation of drive were damages to the switch control cabling, caused by undisclosed external forces.Permobil was able determine how these damages occurred without speculation.The dhr was reviewed, and the device was found to have met specification prior to distribution.

• Brand Name: SMARTDRIVE
• Type of Device: SMARTDRIVE
• Manufacturer (Section D): MAX MOBILITY LLC; 300 duke drive; lebanon TN 37090
• Manufacturer (Section G): MAX MOBILITY LLC; 300 duke drive; lebanon TN 37090
• Manufacturer Contact: kevin bullock ; 300 duke drive; lebanon, TN 37090 ; 8007360925
• MDR Report Key: 15431041
• MDR Text Key: 306407515
• Report Number: 3008370857-2022-00004
• Device Sequence Number: 1
• Product Code: ITI
• UDI-Device Identifier: 00861896000310
• UDI-Public: 00861896000310
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K151199
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MX2+
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/23/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/21/2018
• 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 Sex: Prefer Not To Disclose