MAUDE Adverse Event Report: REWALK ROBOTICS REWALK P5; POWERED EXOSKELETON

Model Number P5

Device Problems Detachment Of Device Component (1104); Crack (1135)

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

Event Date 01/26/2018

Event Type  malfunction  

Event Description

While patient was using rewalk for gait training, the pelvic band cracked and disengaged from the device.

• Brand Name: REWALK P5
• Type of Device: POWERED EXOSKELETON
• Manufacturer (Section D): REWALK ROBOTICS; marlborough MA
• MDR Report Key: 7244557
• MDR Text Key: 99237711
• Report Number: MW5075078
• Device Sequence Number: 1
• Product Code: PHL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 02/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: P5
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 33 YR