MalfunctionBTM
980 VENTILATOR
Received May 31, 2024
Report MW5155702 · MDR key 19450051
Device
Generic name
Ventilator, Emergency, Manual (resuscitator)
Manufacturer
Intersurgical Medical Sdn. Bhd.Model number
2009000Patient
NA · Unknown
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
THE SERVICE PERSONNEL (SP) INSPECTED THE 980 VENTILATOR AND FOUND TIDAL VOLUME WAS LOW DUE TO NON-MEDTRONIC BREATHING CIRCUIT (INTERSURGICAL PATIENT CIRCUIT ) WHICH IS INDEPENDENT OF THE VENTILATOR. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).