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U.S. Department of Health and Human Services

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

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HUDSON RCI, TELEFLEX MEDICAL FLOW INFLATING INFANT AMBU BAG 1/2L HYPERINFLATION SYSTEM WITH MANOMETER VENTILATOR, EMERGENCY, MANUAL (RESUSCITATION) Back to Search Results
Catalog Number 2007HZ
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).
 
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Brand NameFLOW INFLATING INFANT AMBU BAG 1/2L HYPERINFLATION SYSTEM WITH MANOMETER
Type of DeviceVENTILATOR, EMERGENCY, MANUAL (RESUSCITATION)
Manufacturer (Section D)
HUDSON RCI, TELEFLEX MEDICAL
morrisville NC 27560
MDR Report Key8739528
MDR Text Key149520094
Report NumberMW5087643
Device Sequence Number1
Product Code BTM
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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  
0 Patients were Involved in the Event:
Date FDA Received06/26/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number2007HZ
Device Lot Number316763
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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