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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET DATASCOPE CORPORATION CARDIOSAVE HYBRID; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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MAQUET DATASCOPE CORPORATION CARDIOSAVE HYBRID; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number D998-00-0800-53
Device Problems Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/05/2016
Event Type  malfunction  
Event Description
Patient 1; in the cardiac cath lab there was an auto fill failure.Patient 2; the previous shift was having trouble with the waveform on the arterial line.The waveform was almost flat and there was an 'r gas leak' message.The balloon stopped pumping.It was reset and it would work for a while, then the problem recurred.Console was switched out and functional.No harm happened to either patient.Manufacturer response for iabp, cardio save hybrid (per site reporter): they replaced the safety disk and provided more staff education on how to check the safety leak test after each patient use, prior to the next patient use.
 
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Brand Name
CARDIOSAVE HYBRID
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
MAQUET DATASCOPE CORPORATION
cardiac assist division
1300 macarthur boulevard
mahwah NJ 07430
MDR Report Key5754522
MDR Text Key48314726
Report Number5754522
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 User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 06/24/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this a Product Problem Report? Yes
Device Operator No Information
Device Expiration Date06/07/2020
Device Model NumberD998-00-0800-53
Other Device ID NumberDR224015K5
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/24/2016
Device Age6 MO
Event Location Hospital
Date Report to Manufacturer06/24/2016
Initial Date Manufacturer Received Not provided
Initial Date FDA Received06/28/2016
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Treatment
NO.
Patient Age68 YR
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