MalfunctionPJP

BELLE MEDICAL ALERT SYSTEM

Received Nov 4, 2024

Report MW5162184 · MDR key 20611609

Device

Generic name

Fall Prevention Alarm/sensor Attached Only

Manufacturer

Universal Medical Data

Patient

Unknown

No Clinical Signs, Symptoms or Conditions
No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

PATIENT REPORTED THEY HAVE A BELLE MEDICAL ALERT SYSTEM THAT ISN'T CHARGING AND WON'T RESPOND. PATIENT SERVICES REDIRECTED PATIENT TO APPROPRIATE DEVICE MANUFACTURER. "THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2)".