BYTClass IILife-sustaining
Ventilator, External Body, Negative Pressure, Adult (cuirass)
Anesthesiology · 21 CFR 868.5935
MDR events10All time
Recalls0All time
Registered firms10Currently listed
510(k) clearances21All time
Recent MDR events
10 adverse event reports on file
- NEV 100Aug 8, 2018DeathRespironics Inc.2518422-2018-01854
- NEV-100Sep 13, 2011InjuryPhillips RespironicsMW5022255
- NEV 100Dec 21, 2006DeathRespironics, Inc.2518422-2006-00108
- NEV100Apr 8, 2004MalfunctionRespironics, Inc.2518422-2004-00027
- NEV-100Jul 20, 2001DeathRespironics, Inc.2518422-2001-00036
- ADULT VENTILATORAug 1, 1994MalfunctionBear Medical9668
- POSITIVE PRESSURE VENTILATORAug 11, 1993InjuryPuritan Bennett8184
- BEAR 2 ADULT VOLUME VENTILATORAug 11, 1993MalfunctionBear Medical Systems, Inc.8963
- 8400 ST VOLUME VENTILATORApr 9, 1993MalfunctionBird Products5452
- ADULT VENTILATORApr 5, 1993MalfunctionBear Medical Ststems5685
Event type breakdown
Malfunction5
Death3
Injury2
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
10 firms currently registered for this product code
510(k) clearances
21 clearances for this product code
- Medivent LimitedOct 8, 2008
K082657 · RTX RESPIRATOR
- Dima Italia SrlMay 29, 2008
K072290 · PEGASO V, NEGAVENT RESPIRATOR, MODEL: DA-3 PLUS
- Respironics, Inc.Jul 21, 1993
K924341 · HAYEK OSCILLATOR(TM)
- Lifecare Services, Inc.Jun 3, 1991
K910947 · NEV-10 NEGATIVE PRESSURE VENTILATOR
- Puritan Bennett Corp.Mar 1, 1991
K905530 · PURITAN-BENNETT COMPANION 500 LIQUID OXYGEN SYSTEM
- J. H. Emerson Co.Nov 19, 1990
K902764 · EMERSON 33-AN NEGATIVE PRESSURE RESPIRATOR ALARM
- Flexco Medical InstrumentsNov 9, 1990
K903745 · THE HAYEK OSCILLATOR
- Progressive Productions , Ltd.Jul 19, 1990
K902300 · EASY BREATHER MODEL 100 ACCESSORIES