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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AMBU A/S SPUR® II INFANT RESUSCITATORSINGLE PATIENT USE RESUSCITATOR VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)

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AMBU A/S SPUR® II INFANT RESUSCITATORSINGLE PATIENT USE RESUSCITATOR VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR) Back to Search Results
Model Number 544200047
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/22/2017
Event Type  malfunction  
Event Description
Two broken ambu bags were found in the operating room space. The ambu bags appear to have broken where the valve attaches to the bag.
 
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Brand NameSPUR® II INFANT RESUSCITATORSINGLE PATIENT USE RESUSCITATOR
Type of DeviceVENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)
Manufacturer (Section D)
AMBU A/S
sanjay parikh
6230 old dobbin ln ste 250
columbia MD 21045
MDR Report Key6913976
MDR Text Key88157623
Report Number6913976
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 User Facility
Reporter Occupation
Type of Report Initial
Report Date 09/14/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/04/2017
Is this a Product Problem Report? Yes
Device Operator
Device Model Number544200047
Device Catalogue Number544200047
Device Lot Number1861681
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/14/2017
Device Age1 DY
Event Location Hospital
Date Report to Manufacturer09/14/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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