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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 Detachment of Device or Device Component (2907)
Patient Problem Foreign Body In Patient (2687)
Event Type  Injury  
Manufacturer Narrative
As device was not returned from customer, the reported issue cannot be identified.The reported face mask was packed by according to packing procedure and packed in a plastic bag.The mask was made up of dome and cushion, which were combined with glue.A part that can break off from the mask and be swallowed can't be identified from review of similar products or from packaging.For the last 3 years, no complaints with a similar issue has been reported for the spur ii or face mask products.
 
Event Description
An inmate at a prison needed to be resuscitated and the ambu mask (part of the spur ii kit) was used.The customer reported that a piece of the mask broke off and was swallowed by the inmate.The inmate was in critical condition and the customer inferred it was probably due to the mask.
 
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Brand Name
AMBU SPUR II
Type of Device
MANUAL RESUSCITATOR
Manufacturer (Section D)
AMBU A/S
baltorpbakken 13
ballerup, 2750 DK
DA  2750 DK
MDR Report Key12070228
MDR Text Key258601367
Report Number1220828-2019-00012
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 11/17/2019,12/10/2019
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 Catalogue Number520211000
Was the Report Sent to FDA? No
Distributor Facility Aware Date11/15/2019
Event Location Other
Date Report to Manufacturer11/17/2019
Initial Date Manufacturer Received Not provided
Initial Date FDA Received06/25/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Life Threatening;
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