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

Model Number	REWALK PERSONAL P6.0
Medical Device Problem Codes	Fire (1245); Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During a recent review we realized this event should have been reported.
Event or Problem Description
The customer has informed rewalk clinical trainer that the waistpack of the device (where the li-ion battery packs are located) caught fire while it was being charged for approximately 6 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
• Common Device Name: POWERED EXOSKELETON
• Manufacturer (Section D): REWALK ROBOTICS LTD; 3 hatnufa st. (6th floor); yokne'am, 20692 03; IS 2069203
• MDR Report Key: 11655212
• Report Number: 3007615665-2021-00001
• Device Sequence Number: 3449238
• Product Code: PHL
• UDI-Device Identifier: 00861803000303
• UDI-Public: (01)00861803000303
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K160987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Notification,Inspection
• Type of Report: Initial
• Report Date (Section B): 04/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: REWALK PERSONAL P6.0
• Device Catalogue Number: 50-20-0004
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/25/2020
• Initial Report FDA Received Date: 04/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 300761566504/12/2021001C
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 60 YR
• Patient Weight: 80