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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GETINGE / DATASCOPE CORP. MAQUET CARIOSAVE HYBRID SN SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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GETINGE / DATASCOPE CORP. MAQUET CARIOSAVE HYBRID SN SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number SN CH277390D8
Device Problems Pumping Stopped (1503); Failure to Read Input Signal (1581); Application Program Freezes, Becomes Nonfunctional (4031)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/27/2021
Event Type  Injury  
Event Description
Intra- aortic balloon pump was in use on patient. The device stopped pumping and the screen froze and it started alarming with a single long beep. Unable to get screen to functioned, then powering off and back on and the pump started to function normally. This same issue occurred again about 1-2 hours later and then pump was switched out to another machine. Fda safety report id # (b)(4).
 
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Brand NameMAQUET CARIOSAVE HYBRID SN
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
GETINGE / DATASCOPE CORP.
MDR Report Key11769095
MDR Text Key249006978
Report NumberMW5101137
Device Sequence Number1
Product Code DSP
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 04/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/03/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberSN CH277390D8
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: 05/03/2021 Patient Sequence Number: 1
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