MAUDE Adverse Event Report: TISPORT, LLC ZRA; WHEELCHAIR ANTI-TIP

Model Number ZRA

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/20/2018

Event Type  malfunction  

Manufacturer Narrative

No injury was reported in this event.There is a risk of serious injury in the case of a failure of the anti-tips while engaged.The report of this event indicates that the end user was moving up a hill on a grassy surface with an attendant (the patient's mother), and the anti-tip contacted a patch of the grass which caused it to snap off.It is unclear whether the user was reclined on the anti-tips, or propelling with the anti-tips being used as wheels instead of the front casters, which are not recommended by the owners manual, but the owners manual does recommend in chapter 1 section i: -2.Never use your chair on a slope greater than 10%.-9 always lean or press your body in the uphill direction.This will help shift your weight to counteract the change in the center of balance caused by the hill, slope or ramp.The owners manual also warns in chapter 1 warnings section a: -2.If your anti-tips are set too low, they may "catch" on obstacles that you can expect to encounter in normal wheelchair use.If this happens, you may tip over and fall.-4.Always keep your anti-tips locked in place in the "down" position unless: --a.You have an attendant (but your attendant must rotate the anti-tips into the "down" position whenever he or she leaves you unattended in your chair, even for a moment), or --b.You have to climb or descend a curb or step or overcome an obstacle.Even if this is the case, only unlock the anti-tips if you can safely climb or descend the curb or step or overcome the obstacle and make sure the anti-tips are locked in the "up" position.A review of the dhr indicates that the wheelchair passed all applicable quality tests and configuration requirements, and met all specifications as ordered by the dealer when it left the facility.The anti-tip in question was requested to be returned, but has not yet been returned.We do not have any further information about the event, other than these allegations at this time.If more information is provided that changes the nature of the investigation, a follow up medwatch form 3500a will be filed.

Event Description

The dealer relayed that the mother of the patient claims they were going up a hill when one of the anti-tips caught on a grassy patch and snapped.No injury was reported.

• Brand Name: ZRA
• Type of Device: WHEELCHAIR ANTI-TIP
• Manufacturer (Section D): TISPORT, LLC; 2701 w court st; pasco WA 99301
• Manufacturer Contact: brian english ; 2701 w court st; pasco, WA 99301 ; 5095866117
• MDR Report Key: 7891597
• MDR Text Key: 120828519
• Report Number: 3032618-2018-00007
• Device Sequence Number: 1
• Product Code: IMR
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K990358
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 09/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: ZRA
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/20/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/09/2016
• 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