FDA Adverse Event
Malfunction
Summary report: N
REWALK PERSONAL P6.0
MDR report key: 11655212
·
Received April 13, 2021
Report
- Report Number
- 3007615665-2021-00001
- Event Type
- Malfunction
- Date Received
- April 13, 2021
- Date of Event
- March 24, 2020
- Report Date
- April 5, 2021
- Manufacturer
- REWALK ROBOTICS LTD
- Product Code
- PHL
- UDI-DI
- 00861803000303
- PMA / PMN Number
- K160987
- Removal / Correction Number
- 300761566504/12/2021001C
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- 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 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 553249 | REWALK PERSONAL P6.0 | POWERED EXOSKELETON | PHL | REWALK ROBOTICS LTD | REWALK PERSONAL P6.0 | 00861803000303 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Other |