Set, Tubing And Support, Ventilator (w Harness)

Device Code: 74

Product Code(s): BZO

Device Classification Information

• Device Type ID: 74
• Device Name: Set, Tubing And Support, Ventilator (w Harness)
• Regulation Description: Ventilator Tubing.
• Regulation Medical Specialty: Anesthesiology
• Review Panel: Anesthesiology
• Premarket Review: Office Of Device Evaluation (ODE); Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID); Respiratory Devices Branch (RPDB)
• Submission Type: 510(K) Exempt
• CFR Regulation Number: 868.5975 [🔎]
• FDA Device Classification: Class 1 Medical Device
• Product Code: BZO
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

• 1-62 ISO 5356-1 Third Edition 2004-05-15
  Anaesthetic And Respiratory Equipment - Conical Connectors: Part 1: Cones And Sockets
• 1-134 ISO 18562-1 First Edition 2017-03
  Biocompatibility Evaluation Of Breathing Gas Pathways In Healthcare Applications - Part 1: Evaluation And Testing Within A Risk Management Process
• 1-135 ISO 18562-2 First Edition 2017-03
  Biocompatibility Evaluation Of Breathing Gas Pathways In Healthcare Applications - Part 2: Tests For Emissions Of Particulate Matter
• 1-136 ISO 18562-3 First Edition 2017-03
  Biocompatibility Evaluation Of Breathing Gas Pathways In Healthcare Applications - Part 3: Tests For Emissions Of Volatile Organic Compounds
• 1-137 ISO 18562-4 First Edition 2017-03
  Biocompatibility Evaluation Of Breathing Gas Pathways In Healthcare Applications - Part 4: Tests For Leachables In Condensate

Total Product Life Cycle

• Device Type ID: 74
• Device: Set, Tubing And Support, Ventilator (w Harness)
• Product Code: BZO
• FDA Device Classification: Class 1 Medical Device
• Regulation Description: Ventilator Tubing.
• CFR Regulation Number: 868.5975 [🔎]

Device Problems
Device Issue	29
Hole In Material	21
Crack	14
Split	13
Device Operates Differently Than Expected	12
Leak / Splash	11
Disconnection	10
Break	8
Fitting Problem	8
Connection Problem	7
Detachment Of Device Component	5
Material Integrity Problem	4
Gas Leak	3
Physical Property Issue	3
Inadequacy Of Device Shape And/or Size	3
Material Too Rigid Or Stiff	3
Mechanical Problem	3
Overheating Of Device	2
Torn Material	2
Insufficient Information	2
Loose Or Intermittent Connection	2
Device Handling Problem	2
Failure Of Device To Self-Test	2
Device Contamination With Chemical Or Other Material	2
Material Split, Cut Or Torn	2
Use Of Device Problem	2
Obstruction Of Flow	1
Seal	1
Circuit Failure	1
Partial Blockage	1
Breathing Circuit	1
Material Separation	1
Material Torqued	1
Device Damaged Prior To Use	1
Connector	1
Thermal Decomposition Of Device	1
Stretched	1
Collapse	1
Temperature Problem	1
Total Device Problems	188

Recalls
Manufacturer		Recall Class	Date Posted
1	Draeger Medical, Inc.	II	Apr-10-2014
2	Fisher & Paykel Healthcare, Ltd.	I	May-20-2014
3	Hamilton Medical, Inc.	II	Jul-02-2015

TPLC Last Update: 2019-04-02 19:27:53