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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA USA INSPIRE OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS

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LIVANOVA USA INSPIRE OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Device Problems Defective Component (2292); Therapeutic or Diagnostic Output Failure (3023)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/01/2020
Event Type  No Answer Provided  
Event Description
Oxygenator failed: while the patient was on bypass, the heart lung machine oxygenator failed, the patient had to come off bypass for three minutes and the oxygenator was replaced with no apparent injury to the patient.
 
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Brand NameINSPIRE OXYGENATOR
Type of DeviceOXYGENATOR, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
LIVANOVA USA
14401 west 65th way
arvada CO 80004
MDR Report Key11027141
MDR Text Key222041298
Report Number11027141
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 12/09/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/17/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/09/2020
Event Location Hospital
Date Report to Manufacturer12/17/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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