MAUDE Adverse Event Report: REWALK ROBOTICS LTD REWALK PERSONAL P6.0; POWERED EXOSKELETON

Model Number REWALK PERSONAL P6.0

Device Problems Fire (1245); Battery Problem (2885)

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

Event Date 08/25/2018

Event Type  malfunction  

Manufacturer Narrative

During a recent review, we realized this event should have been reported.

Event Description

The customer has informed rewalk business development manager that the waistpack of the device (where the li-ion battery packs are located) caught fire while it was being charged for approximately 48 hours at his house.The customer was not using the system when the incident occurred (the device includes a safety measure that prevents powering on the device while it is being charged).There were no injuries as a result of the incident and there was minor damage caused to the floor where the device was stored.The device was mainly damaged in the waistpack area.

• Brand Name: REWALK PERSONAL P6.0
• Type of Device: POWERED EXOSKELETON
• Manufacturer (Section D): REWALK ROBOTICS LTD; 3 hatnufa st. (6th floor); yokne'am, 20692 03; IS 2069203
• Manufacturer Contact: ishay tal ; 3 hatnufa st. (6th floor); yokne'am, 20692-03 ; IS 2069203
• MDR Report Key: 11655192
• MDR Text Key: 245081609
• Report Number: 3007615665-2021-00002
• Device Sequence Number: 1
• Product Code: PHL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 04/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: REWALK PERSONAL P6.0
• Device Catalogue Number: 50-20-0004
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/27/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/02/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: 300761566504/12/2021001C
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 33 YR
• Patient Weight: 66