MAUDE Adverse Event Report: Y S R PLASTICS INDUSTRIES LTD ADULT ANESTHESIA BREATHING CIRCUIT, 4M, DISPOSABLE, FOR IVENTTM; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)

Catalog Number M1173406

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/08/2018

Event Type  Injury  

Manufacturer Narrative

At this time, vyaire has not received the suspect device/component for evaluation.If additional information becomes available, it will be submitted in a follow up report.

Event Description

The customer reported that halfway through the mri test it was noted that the ivent showed patient tubing error.The device continued ventilating.The respiratory therapist created the mapleson circuit and the doctor manually ventilated the patient throughout the test.The patient was reported to be stable during this time.The customer reported that the device passed ovt (operational verification testing) before patient use.

• Brand Name: ADULT ANESTHESIA BREATHING CIRCUIT, 4M, DISPOSABLE, FOR IVENTTM
• Type of Device: CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
• Manufacturer (Section D): Y S R PLASTICS INDUSTRIES LTD; bar lev industrial zoned.n; misgav 201560; mettawa IL ; IS
• Manufacturer (Section G): Y S R PLASTICS INDUSTRIES LTD; bar lev industrial zoned.n; misgav 201560; IS
• Manufacturer Contact: kristin graf ; 22745 savi ranch parkway; yorba linda, CA 92887
• MDR Report Key: 7424173
• MDR Text Key: 105234854
• Report Number: 2050001-2018-00095
• Device Sequence Number: 1
• Product Code: CAI
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: M1173406
• Device Lot Number: 1145
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/13/2018
• 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