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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 521611001
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/06/2019
Event Type  malfunction  
Event Description
Respiratory therapist entered room of cardiac arrest patient to find patient being mask/ bag ventilated with plastic still over air mask bag unit mask. Plastic was removed and ventilation was resumed. Manufacturer response for air mask bag unit bag, (brand not provided) (per site reporter). The manufacturer is now no longer individually wrapping the mask to prevent this from occurring.
 
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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 Key9595927
MDR Text Key175216796
Report Number9595927
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,Followup
Report Date 12/31/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/16/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number521611001
Device Catalogue Number521611001
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/31/2019
Event Location Hospital
Date Report to Manufacturer01/16/2020
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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