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U.S. Department of Health and Human Services

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

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MAQUET / DATASCOPE CORP. INTRA-AORTIC BALLOON PUMP SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number CS300
Device Problems Loss of Power (1475); Failure to Reset (1532)
Patient Problem No Information (3190)
Event Date 05/06/2019
Event Type  Injury  
Event Description
Balloon pump began alarming low vacuum then suddenly changed to system failure and shut down. Machine unable to be restarted. Treatment had to be terminated as unable to correct machine issue. Fda safety report id# (b)(4).
 
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Brand NameINTRA-AORTIC BALLOON PUMP
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
MAQUET / DATASCOPE CORP.
MDR Report Key8604818
MDR Text Key145023542
Report NumberMW5086576
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 05/08/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/10/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberCS300
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/07/2019
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: 05/10/2019 Patient Sequence Number: 1
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