MAUDE Adverse Event Report: HUDSON RCI, TELEFLEX MEDICAL FLOW INFLATING INFANT AMBU BAG 1/2L HYPERINFLATION SYSTEM WITH MANOMETER; VENTILATOR, EMERGENCY, MANUAL (RESUSCITATION)

Model Number

Device Problems Crack (1135); Defective Device (2588); No Pressure (2994)

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

Event Date 06/13/2019

Event Type  malfunction  

Event Description

Flow inflating neonate ambu bag would not maintain pressure during positive pressure ventilation.New ambu bag defective x3 before functioning bag obtained.Noted that the white plastic ring at the top of the green flow inflating bag where it meets the connection the manometer was cracked.Entire inventory was checked and among dozens of product 15 from 4 different lot numbers were found to be cracked.Distributor was contacted and defective items were removed from stock.Lot numbers and number of that lot number that were found defective: 316763 - 1 bag, 317232 - 3 bags, 317645 - 6 bags, 318787 - 5 bags.Fda safety report id# (b)(4).

• Brand Name: FLOW INFLATING INFANT AMBU BAG 1/2L HYPERINFLATION SYSTEM WITH MANOMETER
• Type of Device: VENTILATOR, EMERGENCY, MANUAL (RESUSCITATION)
• Manufacturer (Section D): HUDSON RCI, TELEFLEX MEDICAL ; morrisville NC 27560
• MDR Report Key: 8739528
• MDR Text Key: 149520094
• Report Number: MW5087643
• Device Sequence Number: 11
• Product Code: BTM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/24/2019
• 15 Devices were Involved in the Event: 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15

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 Model Number

• Device Catalogue Number: 2007HZ
• Device Lot Number: 318787
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/26/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Weight: 3