MalfunctionBTM
980 VENTILATOR
Received Jul 30, 2025 · Event occurred Jan 27, 2025
Report MW5173552 · MDR key 22667818
Device
Generic name
Ventilator, Emergency, Manual (resuscitator)
Manufacturer
Intersurgical Medical Sdn. Bhd.Product problems
- Failure of Device to Self-Test
Patient
NA · Unknown
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
IT WAS REPORTED THAT DURING A PRE-CHECK, THE SHORT SELF TEST (SST) DID NOT PASS ON THE 980 VENTILATORS. THE SERVICE PERSONNEL (SP) INSPECTED THE VENTILATOR AND FOUND CAUSE TRACED TO NON-(B)(6) BREATHING CIRCUIT (INTERSURGICAL PATIENT CIRCUIT) WHICH IS NOT RELATED TO THE VENTILATOR. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).