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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AMBU A/S SPUR® II PEDIATRIC RESUSCITATORW/MANOMETER PEEP VALVE 20; VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)
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AMBU A/S SPUR® II PEDIATRIC RESUSCITATORW/MANOMETER PEEP VALVE 20; VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR) Back to Search Results
Model Number 530613031
Device Problem Defective Device (2588)
Patient Problem Insufficient Information (4580)
Event Date 04/04/2021
Event Type  malfunction  
Event Description
The patient was decompensated and moved to a rest, so they bagged the patient.They intubated the patient and after that back to bagging the patient where they still were not able to create any chest rise and properly oxygenating ventilating him, they switched to another bag, and it was instantly fine.Manufacturer response for ambu bag, pediatric resuscitation bag (per site reporter).The manufacturer is still in the process of figuring out what made the bag fail.We should have some information in few days from the manufacturer.
 
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Brand Name
SPUR® II PEDIATRIC RESUSCITATORW/MANOMETER PEEP VALVE 20
Type of Device
VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)
Manufacturer (Section D)
AMBU A/S
6230 old dobbin ln ste 250
columbia MD 21045
MDR Report Key11811664
MDR Text Key250186581
Report Number11811664
Device Sequence Number1
Product Code BTM
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Type of Report Initial
Report Date 05/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number530613031
Device Catalogue Number530613031
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/06/2021
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/11/2021
Event Location Hospital
Date Report to Manufacturer05/12/2021
Initial Date Manufacturer Received Not provided
Initial Date FDA Received05/12/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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