MAUDE Adverse Event Report: FLEXICARE MEDICAL DONGGUAN LTD. ADULT VENTIMYST DUAL HEATED WIRE BREATHING SYSTEM1.6M (63") KIT 1; HEATED WIRE VENTILATOR BREATHING SYSTEM

Model Number 038-31-252U

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 07/02/2018

Event Type  malfunction  

Manufacturer Narrative

Root cause identified as a poor connection between the pin and the wire in the manufacturing process causing a poor electrical connection in use so the heating wire did not heat or only heated intermittently.Preventative action - introduction of a fixture to test and check the conductivity of the pin and heated wire along with hourly checks of the block to confirm alignment and tightness.

Event Description

Flexicare circuits used on ventilated patients.In each case they heated up exactly as they should and worked great for about 2-3 hours.After approximately 2+ hours each one stopped heating.We have to change to an alternative circuit to get them to heat again.

• Brand Name: ADULT VENTIMYST DUAL HEATED WIRE BREATHING SYSTEM1.6M (63") KIT 1
• Type of Device: HEATED WIRE VENTILATOR BREATHING SYSTEM
• Manufacturer (Section D): FLEXICARE MEDICAL DONGGUAN LTD.; no. b-15 xicheng ind zone 1; hengli town; dongguan city, guangdong 52346 0; CH 523460
• Manufacturer (Section G): FLEXICARE MEDICAL DONGGUAN LTD.; no. b-15 xicheng ind zone 1; hengli town; dongguan city, guangdong 52346 0; CH 523460
• Manufacturer Contact: richard downs ; cynon valley business park; mountain ash, rct CF45 -4ER ; UK CF45 4ER
• MDR Report Key: 8358109
• MDR Text Key: 137062597
• Report Number: 3006061749-2018-00003
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150900
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 038-31-252U
• Device Catalogue Number: 038-31-252U
• Device Lot Number: NOT KNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention