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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORPORATION CARDIOSAVE HYBRID SYSTEM, BALLOON, INTRA-AORTIC

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DATASCOPE CORPORATION CARDIOSAVE HYBRID SYSTEM, BALLOON, INTRA-AORTIC Back to Search Results
Device Problem Inappropriate or Unexpected Reset (2959)
Patient Problem Nausea (1970)
Event Date 11/11/2018
Event Type  malfunction  
Event Description
Iabp stopped (put itself in standby), and alarmed to restart after one minute. Prior to this, the same occurence took place twice on night shift. At this time, patient complained of nausea and was given compazine. The md called as soon as iabp controller was changed out and patient was taken care of.
 
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Brand NameCARDIOSAVE HYBRID
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC
Manufacturer (Section D)
DATASCOPE CORPORATION
1300 macarthur blvd
mahwah NJ 07430
MDR Report Key8128214
MDR Text Key129170611
Report Number8128214
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 Other Health Care Professional
Type of Report Initial
Report Date 11/23/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/04/2018
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/23/2018
Event Location Hospital
Date Report to Manufacturer12/04/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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