MAUDE Adverse Event Report: FLEXICARE MEDICAL DONGGUAN VENTIMYST; ADULT VENTIMYST DUAL HEATED WIRE BREATHING SYSTEM 1.6M KIT 1

Catalog Number 038-31-252U

Device Problems Break (1069); Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/19/2021

Event Type  malfunction  

Event Description

When the user was going to change the circuit, the pigtail became stuck in the circuit and broke during removal.

• Brand Name: VENTIMYST
• Type of Device: ADULT VENTIMYST DUAL HEATED WIRE BREATHING SYSTEM 1.6M KIT 1
• Manufacturer (Section D): FLEXICARE MEDICAL DONGGUAN; no. b-15 xicheng ind zone 1; hengli town; dongguan city, guangdong 52346 0; CH 523460
• MDR Report Key: 11264819
• MDR Text Key: 245101738
• Report Number: 3006061749-2021-00002
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• PMA/PMN Number: N/A#S-P#N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial
• Report Date: 02/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 038-31-252U
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/19/2021
• 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): Other