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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AMBU A/S SPUR II PEDI. BAG RESVR; AMBU SPUR II

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AMBU A/S SPUR II PEDI. BAG RESVR; AMBU SPUR II Back to Search Results
Catalog Number 530613031
Device Problem Gas/Air Leak (2946)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  Death  
Manufacturer Narrative
The sample for the leaking manometer was returned to our manufacturing facility for investigation on may 07, 2021.The sample was immediately evaluated by the qa engineer.The following functional tests were completed on the returned sample: high/low pressure test.Volume test.02 concentration test recoil time test.Each of the above tests that we performed identified no failures with the returned sample.The results of all tests were within the product specifications.As described in the ifu, it is important to inspect the resuscitator and perform a brief functional test prior to use and to not use the product if a test for functionality fails.This mdr is resubmitted again as it was identified that original submission had not been successfully loaded into the fda database due to wrong file format.The initial mdr of this incident was submitted to the fda within the original reporting deadline.This submission represents a reload of data to ensure correct upload to the fda database.
 
Event Description
Per customer patient was quickly moved to picu (pediatric intensive care unit) and was in process of decompensating.His hgb was only a bit over 2 so did not have any reserve.Spur ii resuscitator was leaking around manometer port which affected the patient and the patient was decompensating.Back up resuscitator was not available.Information was provided on 19th of april 2021 that patient expired, customer mentioned that the resuscitator was not the cause of the outcome.
 
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Brand Name
SPUR II PEDI. BAG RESVR
Type of Device
AMBU SPUR II
Manufacturer (Section D)
AMBU A/S
baltorpbakken 13
ballerup, dnk 2750
DA  2750
MDR Report Key11984156
MDR Text Key255670228
Report Number1220828-2021-00009
Device Sequence Number1
Product Code BTM
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date 04/08/2021,05/17/2021
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 Number530613031
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/07/2021
Was the Report Sent to FDA? No
Event Location Hospital
Date Report to Manufacturer04/08/2021
Initial Date Manufacturer Received Not provided
Initial Date FDA Received06/11/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Death;
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