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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AMBU, INC. MCKESSON DISPOSABLE HYPERINFLATION SYSTEM 1/2 L BAG VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)

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AMBU, INC. MCKESSON DISPOSABLE HYPERINFLATION SYSTEM 1/2 L BAG VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR) Back to Search Results
Catalog Number 900000607
Device Problem Material Separation (1562)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/06/2020
Event Type  malfunction  
Event Description
Disposable ambu hyperinflation system 1/2 l green bag is consistently separating from white plastic piece that connects the bag to the mask for neonatal resuscitation. No harm to date but has a potential for harm. Noted by staff in the packaging bag when obtaining several of these items; none were useable.
 
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Brand NameMCKESSON DISPOSABLE HYPERINFLATION SYSTEM 1/2 L BAG
Type of DeviceVENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)
Manufacturer (Section D)
AMBU, INC.
6230 old dobbin ln ste 250
columbia MD 21045
MDR Report Key9753217
MDR Text Key180894639
Report Number9753217
Device Sequence Number1
Product Code BTM
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 01/14/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/26/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number900000607
Device Lot Number092719N02
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/14/2020
Event Location No Information
Date Report to Manufacturer02/26/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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