MAUDE Adverse Event Report: MERITS HEALTH PRODUCTS CO., LTD. NLA_PRONTO31 PWR BASE W/18X18 SEMI-RECL STYLE SEAT BLUE; WHEELCHAIR, POWERED

Model Number NA:P31BLUE

Device Problem Disconnection (1171)

Patient Problem Laceration(s) (1946)

Event Date 03/29/2018

Event Type  Injury  

Manufacturer Narrative

On (b)(6) 2018, the caregiver reported that the joystick was falling off, and was being held on by electrical tape, causing it not to make a good connection from the joystick to the controller on the back of the chair.The end user has issues controlling the chair at times and forgetting to remove their hand completely from the joystick when stopping.They have been advised to turn off the chair and remove their hand from joystick when stopping.On 04/16/2018, invacare spoke with the provider who stated that they have the chair in their repair shop being serviced.  they tested the chair¿s electronics, including the joystick and controller and found no malfunctions.  the loss of connection was caused by the joystick and controller falling off the back of the chair.  the joystick and controller were being held on by electrical tape causing them not to make a good connection.  the most probable cause of the incident was the loss of connection due to the end user improperly attaching the joystick and controller.  the provider will send the service report when completed.  the wheelchair will not be returned to invacare for evaluation because it has been evaluated and serviced by the dealer.A follow-up report will be filed if more information is received.

Event Description

The consumers' caregiver states the joystick is falling off the chair and is being held on by electrical tape.The chair isn't stopping when being given the command, due to not having a good connection from the joystick, to the controller on the back of the chair.The consumer ran into the open door of her vehicle and hit the sharp part of the bottom of the door causing a large laceration to his lower leg requiring 21 stitches.

• Brand Name: NLA_PRONTO31 PWR BASE W/18X18 SEMI-RECL STYLE SEAT BLUE
• Type of Device: WHEELCHAIR, POWERED
• Manufacturer (Section D): MERITS HEALTH PRODUCTS CO., LTD.; 18 jingke road; taichung city, nantun district 40852 ; TW 40852
• MDR Report Key: 7468106
• MDR Text Key: 106719772
• Report Number: 1531186-2018-00004
• Device Sequence Number: 1
• Product Code: ITI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial
• Report Date: 04/17/2018,03/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: NA:P31BLUE
• Device Catalogue Number: P31BLUE
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/30/2018
• Device Age: 3 YR
• Date Report to Manufacturer: 04/17/2018
• Date Manufacturer Received: 04/16/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other