MAUDE Adverse Event Report: VITAL SIGNS INC. CLASSIC HYPERINFLATION SYSTEM 0.5L; AMBU BAG

Model Number 5104RDV2

Device Problems Loose or Intermittent Connection (1371); Decrease in Pressure (1490); Overfill (2404)

Patient Problem No Information (3190)

Event Date 08/13/2015

Event Type  Injury  

Event Description

Neonatal resuscitation ventilatory support.Ambu back of type described below a pressure regulation air exit valve (could send fda picture when this would allow.Please provide for such in the future.) that is operated by a completely loose mounted cap with no provisions for an arretation.This "valve" came in contact with the infant warmer bedding, the gown of myself, the belly on a very experienced anaesthesiologist and our assisting nurse(s) and respiratory therapist during "cpap" and "bagging" the infant, as well during and after intubation.This, under the circumstance unavoidable contact with this loose valve led to sudden drops to pressure in the bag as well as rapid overinflation.Dose or amount: room air/02.Frequency: manual.Route: respiratory.Dates of use: (b)(6) 2015.Diagnosis or reason for use: infant resuscitation, ventilatory support.

• Brand Name: CLASSIC HYPERINFLATION SYSTEM 0.5L
• Type of Device: AMBU BAG
• Manufacturer (Section D): VITAL SIGNS INC.
• MDR Report Key: 5035614
• MDR Text Key: 24367885
• Report Number: MW5055774
• Device Sequence Number: 1
• Product Code: BTM
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Report Date: 08/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5104RDV2
• Device Lot Number: 11038A
• Other Device ID Number: VSI5124RDXV
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention; Disability