MAUDE Adverse Event Report: VYAIRE MEDICAL ANESTHESIA CIRCUIT, ADULT, 180 IN. EXPANDABLE; ANESTHESIA BREATHING CIRCUIT

Catalog Number A9UX2XXX

Device Problems Loose or Intermittent Connection (1371); Premature Separation (4045)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/11/2018

Event Type  Injury  

Manufacturer Narrative

At this time, the suspect component is not available for return.Due to the part not being available to be returned, no further evaluation can be completed at this time.

Event Description

Customer reported: on the swivel elbow there are two black rubber bands, these are supposed to keep the circuit from falling apart but it looks as though they are failing.The customer reported there is no patient impact associated with the event.

Manufacturer Narrative

The device sample was not available for investigation, but a photo provided by the customer.According to the investigation, even though the defect reported by the customer could be confirmed with the picture provided, a root cause could not be determined without the physical sample in order to perform a complete investigation.

• Brand Name: ANESTHESIA CIRCUIT, ADULT, 180 IN. EXPANDABLE
• Type of Device: ANESTHESIA BREATHING CIRCUIT
• Manufacturer (Section D): VYAIRE MEDICAL; 22745 savi ranch pkwy; yorba linda CA 92887
• MDR Report Key: 8222580
• MDR Text Key: 132244851
• Report Number: 8030673-2019-00022
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 12/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: A9UX2XXX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2018
• Initial Date Manufacturer Received: 12/11/2018
• Initial Date FDA Received: 01/07/2019
• Supplement Dates Manufacturer Received: 01/04/2019
• Supplement Dates FDA Received: 02/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention