MAUDE Adverse Event Report: CAREFUSION/VYAIRE MEDICAL, INC. VITAL SIGNS LIMB-O SINGLE LIMB ANESTHESIA; BREATHING CIRCUIT

Model Number C-ASMXXXX

Device Problem Communication or Transmission Problem (2896)

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

Event Date 02/02/2018

Event Type  malfunction  

Event Description

Gas line sample port does not communicate with gas sample line.Hole in elbow is blocked.Dates of use: (b)(6) 2018.Is the product compounded: no.Is the product over-the-counter: no.Event abated after use stopped or dose reduced.Yes.

• Brand Name: VITAL SIGNS LIMB-O SINGLE LIMB ANESTHESIA
• Type of Device: BREATHING CIRCUIT
• Manufacturer (Section D): CAREFUSION/VYAIRE MEDICAL, INC. ; 26125 n. riverwoods blvd.; mettawa IL 60045
• MDR Report Key: 7316799
• MDR Text Key: 101838989
• Report Number: MW5075680
• Device Sequence Number: 1
• Product Code: CAG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/02/2021
• Device Model Number: C-ASMXXXX
• Device Lot Number: 0001189444
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Weight: 88