MAUDE Adverse Event Report: MOTEK MEDICAL B.V. BODY WEIGHT SUPPORT LIGHT; POWERED EXERCISER

Model Number RB011

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 07/25/2023

Event Type  malfunction  

Event Description

Customer reported that during treatment, the patient rolled ankle on affected le.Pt was practicing ambulation w/op afo.Treadmill speed was assessing and slower than normal to accommodate walking sans bracing.Due to rolled ankle, patient tripped and fell upon harness safety strap failing.Allegedly, the stitching on the harness buckle attaching to the overhead body weight support popped all the way through allowing the strap to come apart and slide through the supporting carabiner.Customer reported that the emergency stop was immediately pressed halting the treadmill.Customer reported that pt was immediately assessed, no reports of pain and no visible injuries.Measures were taken for soft tissue injuries to le.No medical measures were needed and pt was able to continue therapy as scheduled.

• Brand Name: BODY WEIGHT SUPPORT LIGHT
• Type of Device: POWERED EXERCISER
• Manufacturer (Section D): MOTEK MEDICAL B.V.; vleugelboot 14; houten, utrecht 3991 CL; NL 3991 CL
• Manufacturer (Section G): MOTEK MEDICAL B.V.; vleugelboot 14; houten, utrecht 3991 CL; NL 3991 CL
• Manufacturer Contact: kevin walls ; 33 golden eagle lane; littleton, CO 80127 ; 7209625412
• MDR Report Key: 17433390
• MDR Text Key: 320144641
• Report Number: 3006750942-2023-00001
• Device Sequence Number: 1
• Product Code: BXB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 08/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RB011
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1