inforMED
MalfunctionBTM

980 VENTILATOR

Received Jul 16, 2024

Report MW5157350 · MDR key 19765327

Device

Generic name

Ventilator, Emergency, Manual (resuscitator)

Model number

2009000

Patient

NA · Unknown

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

Narrative

Description of Event or Problem

THE SERVICE PERSONNEL (SP) INSPECTED THE 980 VENTILATOR AND FOUND TIDAL VOLUME ¿NOT DELIVER¿ DUE TO NON-MEDTRONIC BREATHING CIRCUIT (INTERSURGICAL PATIENT CIRCUIT ) WHICH IS INDEPENDENT OF THE VENTILATOR. SINCERELY. DISCLAIMER STATEMENT: THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).