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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device ventilator, emergency, manual (resuscitator)
Regulation Description Manual emergency ventilator.
Product CodeBTM
Regulation Number 868.5915
Device Class 2


Premarket Reviews
ManufacturerDecision
ALLIED HEALTHCARE PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 4
AMBU INTERNATIONAL A/S
  SUBSTANTIALLY EQUIVALENT 18
ENGINEERED MEDICAL
  SUBSTANTIALLY EQUIVALENT 6
GALEMED CORP.
  SUBSTANTIALLY EQUIVALENT 1
HUDSON RESPIRATORY CARE
  SUBSTANTIALLY EQUIVALENT 2
JOHNSON & JOHNSON
  SUBSTANTIALLY EQUIVALENT 1
KIRK SPECIALTY
  SUBSTANTIALLY EQUIVALENT 2
LAERDAL MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 3
LIFE SUPPORT PRODUCTS
  SUBSTANTIALLY EQUIVALENT 6
MCKESSON
  SUBSTANTIALLY EQUIVALENT 1
MERCURY MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
NELLCOR PURITAN BENNETT
  SUBSTANTIALLY EQUIVALENT - KIT 1
  SUBSTANTIALLY EQUIVALENT 15
NEOMED
  SUBSTANTIALLY EQUIVALENT 1
OHMEDA MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
O-TWO SYSTEMS INTL., INC.
  SUBSTANTIALLY EQUIVALENT 3
PORTEX, INC.
  SUBSTANTIALLY EQUIVALENT 2
PRECISION MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
PROMEDIC, INC.
  SUBSTANTIALLY EQUIVALENT - KIT 1
RESPIRONICS, INC.
  SUBSTANTIALLY EQUIVALENT 5
RESUSCITATION ACE, INC.
  SUBSTANTIALLY EQUIVALENT 1
RUSCH, INC.
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS
  SUBSTANTIALLY EQUIVALENT 1
SIMS
  SUBSTANTIALLY EQUIVALENT 3
Ventlab Corporation
  SUBSTANTIALLY EQUIVALENT 2
VITAL SIGNS, INC.
  SUBSTANTIALLY EQUIVALENT 6

Device Problems
No flow 71
Failure to deliver 69
Defective item 19
Crack 7
Inflation issue 7
Misassembled 6
Detachment of device component 6
Use of Device Issue 5
Device damaged prior to use 5
Gas delivery system failure 4
Disconnection 4
Seal, defective 4
Device Issue 4
Device operates differently than expected 4
Unknown (for use when the device problem is not known) 4
Component or accessory incompatibility 3
Component missing 3
Maintenance does not comply to manufacturers recommendations 3
Device handling issue 3
Mechanical issue 3
Imprecision 2
Deflation, cause unknown 2
Air leak 2
Blockage within device or device component 2
Burn of device or device component 2
Detachment of device or device component 2
No Known Device Problem 2
No Information 1
Improper device output 1
Improper flow or infusion 1
Delivery system failure 1
Residue after decontamination 1
Aspiration issue 1
Blocked connection 1
Pressure, insufficient 1
Malfunction 1
Dent in material 1
Device Cleaning Issue 1
Device clogged 1
Component(s), broken 1
Break 1
Connection error 1
Deflation issue 1
Difficult to deploy 1
Cross connection 1
Decoupling 1
Dislodged 1
Electrical issue 1
Energy output to patient tissue incorrect 1
Fire 1
Restricted flowrate 1
Hole in material 1
Leak 1
Loose or intermittent connection 1
Magnet mode discrepancy 1
Defective component 1
Valve(s), defective 1
Valve(s), failure of 1
Fitting problem 1
Pressure sensor failure 1
Seal, incorrect 1
Stuck in inspiratory or expiratory phase 1
Total Device Problems 283

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

Recalls
Manufacturer Recall Class Date Posted
1 Carefusion 2200 Inc II Aug-13-2013
2 GE Healthcare II Feb-03-2014
3 GE Healthcare, LLC I Feb-25-2014
4 GE Healthcare, LLC I Feb-08-2013
5 Precision Medical, Inc. II May-09-2010
6 Teleflex Medical I Jun-24-2015
7 Unomedical I Nov-04-2009
8 Ventlab Corporation I Nov-01-2012
9 Ventlab LLC I Jul-03-2014
10 Westmed Inc I Sep-08-2010

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