FDA Adverse Event
Malfunction
Summary report: N
REWALK PERSONAL P6.0
MDR report key: 11655192
·
Received April 13, 2021
Report
- Report Number
- 3007615665-2021-00002
- Event Type
- Malfunction
- Date Received
- April 13, 2021
- Date of Event
- August 25, 2018
- Report Date
- April 7, 2021
- Manufacturer
- REWALK ROBOTICS LTD
- Product Code
- PHL
- PMA / PMN Number
- K160987
- Removal / Correction Number
- 300761566504/12/2021001C
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 1
DURING A RECENT REVIEW, WE REALIZED THIS EVENT SHOULD HAVE BEEN REPORTED.
Description of Event or Problem · 1
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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 552892 | REWALK PERSONAL P6.0 | POWERED EXOSKELETON | PHL | REWALK ROBOTICS LTD | REWALK PERSONAL P6.0 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 33 YR | Other |