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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device ventilator, emergency, powered (resuscitator)
Regulation Description Powered emergency ventilator.
Product CodeBTL
Regulation Number 868.5925
Device Class 2


Premarket Reviews
ManufacturerDecision
AIRON CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ALLIED HEALTHCARE PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 9
AMBU INTERNATIONAL A/S
  SUBSTANTIALLY EQUIVALENT 1
ATOM MEDICAL INC
  SUBSTANTIALLY EQUIVALENT 1
BIOVNA MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
IMPACT INSTRUMENTATION, INC.
  SUBSTANTIALLY EQUIVALENT 5
INTERNATIONAL BIOMEDICAL
  SUBSTANTIALLY EQUIVALENT 1
JOHNSON & JOHNSON
  SUBSTANTIALLY EQUIVALENT 1
LIFE SUPPORT PRODUCTS
  SUBSTANTIALLY EQUIVALENT 8
MERCURY MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
OHMEDA MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
O-TWO SYSTEMS INTL., INC.
  SUBSTANTIALLY EQUIVALENT 7
PNEUPAC LTD.
  SUBSTANTIALLY EQUIVALENT 1
SMITHS
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Device Issue 24
Failure to cycle 21
Device alarm system issue 11
Break 9
Malfunction 7
Device handling issue 7
Crack 6
Unknown (for use when the device problem is not known) 5
Device operates differently than expected 5
Defective component 3
Foreign material present in device 3
Power source issue 3
Other (for use when an appropriate device code cannot be identified) 3
Electrical issue 3
Tidal volume fluctuations 3
Inadequate service 3
Mechanical issue 2
Device inoperable 2
Failure to charge 2
Circuit Failure 2
Measurements, inaccurate 2
False device output 2
Pressure issue 2
No flow 2
No Pressure 2
Failure to deliver 2
Free or unrestricted flow 2
Infusion or flow issue 2
Device displays error message 2
Battery issue 2
Charging issue 2
Connection issue 2
Split 1
Delayed charge time 1
Maintenance does not comply to manufacturers recommendations 1
Medical Gas Supply problem 1
Improper alarm 1
Valve(s), defective 1
Fail-safe mechanism issue 1
Failure of device to self-test 1
Programming issue 1
False reading from device non-compliance 1
Restricted flowrate 1
Improper gas output 1
Intraprocedure, fire or flash during 1
Leak 1
Incorrect measurement 1
Air leak 1
Alarm, audible 1
Deflation issue 1
Collapse 1
Corrosion 1
False alarm 1
Defective Alarm 1
Alarm, failure of low flow 1
Alarm, failure of warning 1
Use of Device Issue 1
Respirator, detachment from 1
Transducer probe overheating 1
Fail-safe design failure 1
Meter 1
Misassembled 1
Misconnection 1
Incorrect or inadequate result 1
Slippage of device or device component 1
Sticking 1
Device stops intermittently 1
Total Device Problems 183

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 1 1 2 0 1
Class II 1 0 0 0 0 0 1 1 1 1
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Draeger Medical Systems, Inc. I Apr-10-2014
2 GE Healthcare II Feb-03-2014
3 GE Healthcare, LLC I Feb-25-2014
4 GE Healthcare, LLC I Feb-08-2013
5 GE Healthcare, LLC I Dec-26-2012
6 Impact Instrumentation, Inc. II Jun-26-2015
7 Instrumentation Industries Inc II Apr-16-2013
8 Mercury Enterprises, Inc. dba Mercury Medical II Jan-12-2016
9 Smiths Medical PM, Inc. II Jul-04-2007
10 Thornhill Research Inc I Jan-11-2016

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