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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 522611000
Device Problems Component Missing (2306); Therapeutic or Diagnostic Output Failure (3023)
Patient Problems Cardiac Arrest (1762); Respiratory Arrest (4461)
Event Date 01/25/2021
Event Type  Death  
Event Description
Patient was not receiving adequate ventilation during code blue resuscitation event. It was identified that the ambu bag was missing the white screw in pressure limiting cap. Manufacturer indicated cap is designed to be removable to allow user to clear the valve chamber. The pressure limiting cap should never be removed during operation. Our organization identified ambu packaging can be opened and product manipulated through the package handle. Packaging can be opened/closed and appear unopen. Covid air-borne precaution filters have changed resuscitator product handling for hospitals globally. Filter connections can be confusing (many different products). Opportunity for manufacturer to create an ambu bag that does not have removable piece that makes product inoperable. Other option is to visually indicate piece should not be removed.
 
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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 Key11473120
MDR Text Key239444932
Report Number11473120
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 02/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/12/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number522611000
Device Catalogue Number522611000
Device Lot Number1000422792
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/15/2021
Event Location Hospital
Date Report to Manufacturer03/12/2021
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 Unkown

Patient Treatment Data
Date Received: 03/12/2021 Patient Sequence Number: 1
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