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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AMBU A/S SPUR II ADULT RESUSCITATOR; VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)
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AMBU A/S SPUR II ADULT RESUSCITATOR; VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR) Back to Search Results
Device Problems No Flow (2991); Therapeutic or Diagnostic Output Failure (3023)
Patient Problems Loss of consciousness (2418); Low Oxygen Saturation (2477)
Event Date 10/30/2021
Event Type  malfunction  
Event Description
Patient was in dialysis receiving her first intermittent haemodialysis run and an hour into her run, went unresponsive (gcs 4).Patient started desaturating, close face mask applied at "flush" rate.Patient still unable to maintain good saturations.Emergency ambu bag that was in room was accessed and hooked up to oxygen, applied over mouth, however the patient continued to desaturate despite attempting manual breaths and being hooked up to oxygen through ambu bag tubing.Patient placed back onto closed face mask and rrt arrived at beside.Ambu bag was hooked up to another oxygen tree in another room to assess quality and function and was found to be malfunctioned, not allowing any air through the mask.
 
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Brand Name
SPUR II ADULT RESUSCITATOR
Type of Device
VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)
Manufacturer (Section D)
AMBU A/S
6230 old dobbin ln ste 250
columbia MD 21045
MDR Report Key12786305
MDR Text Key280585066
Report Number12786305
Device Sequence Number1
Product Code BTM
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/10/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/05/2021
Device Age6 YR
Event Location Hospital
Date Report to Manufacturer11/10/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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