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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET / DATASCOPE CORP. MAQUET IABP SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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MAQUET / DATASCOPE CORP. MAQUET IABP SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number SENSATION 7FR 34CC
Device Problems Material Rupture (1546); Self-Activation or Keying (1557)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/13/2019
Event Type  Injury  
Event Description
Pt with intra-aortic balloon pump, started to alarm and automatically switched to "stand by" mode. Line filled with blood. Pt had to have line pulled emergently. Upon examination, it was found the balloon had ruptured. Pt tolerated event well. Fda safety report id# (b)(4).
 
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Brand NameMAQUET IABP
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
MAQUET / DATASCOPE CORP.
MDR Report Key9226026
MDR Text Key163754114
Report NumberMW5090597
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 10/21/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/22/2019
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberSENSATION 7FR 34CC
Device Lot Number30000876800273
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 10/22/2019 Patient Sequence Number: 1
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