MAUDE Adverse Event Report: VYAIRE MEDICAL, INC. / CAREFUSION HYPERINFLATION SYSTEM; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Catalog Number 510RCV1

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 07/02/2019

Event Type  malfunction  

Event Description

Vyaire hyperinflation bag mislabeled, package showed 1/2 liter bag, contents was a 1 l hyperinflation bag.Fda safety report id#: (b)(4).

• Brand Name: HYPERINFLATION SYSTEM
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): VYAIRE MEDICAL, INC. / CAREFUSION
• MDR Report Key: 8767979
• MDR Text Key: 150443031
• Report Number: MW5087914
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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: No Information
• Device Catalogue Number: 510RCV1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/05/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1