Z-1142-2023 Class I Ongoing

Life2000 Ventilator , REF MS-01-0118, ventilatory support for the care of individuals

There is the potential for patient desaturation events to occur under certain scenarios when the Life2000 ventilation system is connected with an oxygen concentrator.

UDI 00887761978089, Serial Numbers: L1912010-050, L1905010-081, L1912010-037, L1903102-024, L1912025-024, L1903103-011, L1911019-026, L1912013-045, L1912013-036, L1905010-028, L1903102-028, L1905010-089, L1912013-019, L1903102-010, L1903103-026, L1905010-058, L1903097-007, L1903103-003, L1905010-092, L1903102-019, L1903102-013, L1904038-002, L1905010-051, L1903097-012, L1905010-018, L1904038-001, L1903103-004, L1912013-032, L1904038-003, L1911019-025, L1904050-001, L1905010-059, L1905010-088, L1911019-033, L1903103-001, L1903103-009, L1912013-013, L1903102-025, L1903103-002, L1912013-006, L1911019-010, L1912010-030, L1903097-018, L1912025-021, L1905010-004, L1903103-030, L1911019-027, L1903102-020, L1905010-041, L1912013-031, L1905010-033, L1905010-056, L1912013-041, L1905010-082, L1912010-003, L1912010-035, L1903103-014, L1912013-035, L1912010-034, L1912013-008, L1903103-027, L1903103-007, L1911019-014, L1905010-021, L1912025-019, L1903103-012, L1911019-037, L1912010-002, L1903103-010, L2001042-022, L1912025-007