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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP CARDIOSAVE HYBRID SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE CORP CARDIOSAVE HYBRID SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Device Problems Device Displays Incorrect Message (2591); Pressure Problem (3012); Temperature Problem (3022)
Patient Problem Insufficient Information (4580)
Event Date 02/09/2022
Event Type  malfunction  
Event Description
Sudden alarm observed for "device over temperature threshold" and iabp noted to have entered stand-by mode. Attempted to trouble shoot device but unable to re-start pump. Iabp console was exchanged to back-up console. Upon connecting pressure cable (iabp was not fiber optic), new console not registering presence of a pressure cable and we were unable to zero the transducer. Iabp was functioning normally throughout this process and timing on the ecg trigger. Unable to successfully obtain pressure monitoring so decision was made to switch patient back to original iabp controller. Patient was safely transitioned and iabp was re-started at 1:1 timing without incident. At this time, another backup iabp console was obtained in case of recurrence. Approximately 1h later, console entered standby mode and re-alarmed for "high temperature". Patient was quickly transitioned to new back up controller and no further alarms were noted. Overtemp unit was brought to clinical engineering for evaluation. No overtemp alarm messages were found in the alarm log. Unit was run for 3 hours with no observed issues. This unit recently had the compressor replaced on pm. Unit was run overnight (14 hours) with no issues and returned to service. Another console was tested by occluding the air line on the compressor and was able to generate an over temp alarm and shut down. Verified that this alarm does not appear in the log file. Unit with pressure problem was tested and verified the pressure input was not working. Manufacturer response for intraortic balloon pump, (brand not provided) (per site reporter): manufacturer field service rep verified bad pressure board. Pressure board was replaced and unit returned to service. Manufacturer response for intraortic balloon pump, (brand not provided) (per site reporter): manufacturer field service rep evaluated unit and was unable to duplicate problem.
 
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Brand NameCARDIOSAVE HYBRID
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP
15 law drive
fairfield NJ 07004
MDR Report Key13633718
MDR Text Key286338625
Report Number13633718
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 Biomedical Engineer
Type of Report Initial
Report Date 02/18/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/01/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/18/2022
Device Age7 YR
Event Location Hospital
Date Report to Manufacturer03/01/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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