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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AMBU A/S SPUR® II ADULT RESUSCITATORSINGLE PATIENT USE RESUSCITATOR VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)

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AMBU A/S SPUR® II ADULT RESUSCITATORSINGLE PATIENT USE RESUSCITATOR VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR) Back to Search Results
Model Number 520611000
Device Problems Disconnection (1171); Defective Device (2588)
Patient Problem Death (1802)
Event Date 10/01/2018
Event Type  Death  
Event Description
Patient coding. Ambu brand resuscitation bag removed from packaging and placed into use. Bag became disconnected in two connections. Peep valve continued to pop off during use. Resqpod placed between endotracheal tube and bag connection popped off on every breath causing the therapists to manually hold the resqpod onto the bag with every breath. Therapist should be able to hold the tube with spare hand but was required to keep the bag/valve/pod in place. The patient expired. Could the bag popping off and not holding peep or doing what it needed have contributed? we have no way of knowing but ambu bags are not where we should be cutting costs. We need reliable bags.
 
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Brand NameSPUR® II ADULT RESUSCITATORSINGLE PATIENT USE RESUSCITATOR
Type of DeviceVENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)
Manufacturer (Section D)
AMBU A/S
6230 old dobbin ln ste 250
columbia MD 21045
MDR Report Key8073190
MDR Text Key127239726
Report Number8073190
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 Other Health Care Professional
Type of Report Initial
Report Date 10/15/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/15/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number520611000
Device Catalogue Number520611000
Device Lot Number1000129914
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/15/2018
Event Location Other
Date Report to Manufacturer11/15/2018
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?
Type of Device Usage

Patient Treatment Data
Date Received: 11/15/2018 Patient Sequence Number: 1
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