HARMONY SHR
Received Mar 18, 2024 · Event occurred Feb 1, 2024
Report 3019887527-2024-00001 · MDR key 18920917
Device
Generic name
Upper Extremity Robotic Rehabilitation Device
Manufacturer
Harmonic Bionics Inc.Model number
M1-00001Catalog number
A1-00-0000-00
Lot number
2401
Product problems
- Smoking
- Smoking
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE AFFECTED COMPONENT IS BEING SENT TO HARMONIC BIONICS FROM THE DISTRIBUTOR FOR EVALUATION AND FURTHER INVESTIGATION. AS A PRECAUTION, COMMUNICATION WAS SENT TO OTHER CUSTOMERS ON (B)(6) 2024 TO ALERT THEM OF THE POTENTIAL FOR MALFUNCTION. THIS IS HARMONIC BIONICS' FIRST EMDR SUBMISSION. AS A RESULT, THE REPORT WAS DELAYED DUE TO THE SIGNUP PROCESS. THIS STATEMENT IS PER GUIDANCE FROM (B)(6).
Description of Event or Problem
DURING A PRODUCT DEMONSTRATION, THE CUSTOMER ENGAGED THE MECHANICAL EMERGENCY STOP ON THE DEVICE AND OBSERVED THE PRESENCE OF SMOKE IN THE REAR ENCLOSURE. NO USER/PATIENT WAS IN THE DEVICE DURING THE DEMONSTRATION.