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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GETINGE GROUP INTRA-AORTIC BALLOON PUMP SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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GETINGE GROUP INTRA-AORTIC BALLOON PUMP SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Device Problem Fluid Leak (1250)
Patient Problem Insufficient Information (4580)
Event Date 07/13/2021
Event Type  malfunction  
Event Description
The patient had an iabp inserted as part of the cardiac support and treatment. The patient arrived from the or with the iapb catheter in place. It was working fine. At some point during the shift the catheter was repositioned by the providers. Several hours later the rn went to assess the insertion site and found that there was blood in the helium line. The iabp console began to alarm "helium leak". Rn notified the provider team and the iabp was removed from the patient's groin. The patient remained stable and tolerated the catheter being removed. Manufacturer response for intra aortic balloon pump, (brand not provided) (per site reporter). Response has been good.
 
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Brand NameINTRA-AORTIC BALLOON PUMP
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
GETINGE GROUP
45 barbour pond drive
wayne NJ 07470
MDR Report Key12280460
MDR Text Key265165220
Report Number12280460
Device Sequence Number1
Product Code DSP
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 07/22/2021,07/13/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/05/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/22/2021
Event Location Hospital
Date Report to Manufacturer08/05/2021
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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