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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AMBU A/S AMBU SPUR II; MANUAL RESUSCITATOR
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AMBU A/S AMBU SPUR II; MANUAL RESUSCITATOR Back to Search Results
Catalog Number 520211000
Device Problem Inflation Problem (1310)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/03/2020
Event Type  Injury  
Manufacturer Narrative
The reported product was controlled in ambu production line and the functional tests were performed and passed.The product was within specifications when leaving the manufacturing site.The reported issue that the bag could not inflate can be due to a mechanical defect such as deformation due to improper storage or during transportation.The customer confirmed that he expected that storage or transportation issues had affected the product.However, as no sample was received the root cause could not be established.Additionally, as per stated in the ifu, a functional test of the device shall always be performed prior to use, in order to detect defects like this prior to use on a patient.The patient has been discharged from the hospital and back in her county of residence.Fda report reference number: mw5096666.
 
Event Description
The face mask (spur ii) would not inflate and therefore it was not able to provide rescue breathing to the patient.
 
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Brand Name
AMBU SPUR II
Type of Device
MANUAL RESUSCITATOR
Manufacturer (Section D)
AMBU A/S
baltorpbakken 13
ballerup, denmark 2750
DA  2750
MDR Report Key11957525
MDR Text Key255055910
Report Number1220828-2020-00011
Device Sequence Number1
Product Code BTM
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Type of Report Initial
Report Date 11/16/2020,12/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number520211000
Device Lot Number1673030
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location Other
Date Report to Manufacturer11/16/2020
Initial Date Manufacturer Received Not provided
Initial Date FDA Received06/08/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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