InjuryBZD
2 MAX TRIO SYSTEM
Received Jan 31, 2025 · Event occurred Jan 20, 2025
Report MW5165576 · MDR key 21297838
Device
Generic name
Ventilator, Non-continuous (respirator)
Manufacturer
Pulmodyne Inc.Patient
88 YR · Female
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
PULMODYNE CPAP (CONTINUOUS POSITIVE AIRWAY PRESSURE) DEVICE EXPERIENCED A MALFUNCTION THAT APPEARED TO BE DUE TO A DEFECTIVE SEAL AROUND ONE OF THE HOSES. THIS MALFUNCTION CAUSED A LAPSE IN PATIENT CARE AND HAS BEEN DOCUMENTED AS SUCH.