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U.S. Department of Health and Human Services

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

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DATASCOPE CORP. CARDIOSAVE SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Device Problems Thermal Decomposition of Device (1071); Mechanical Jam (2983); Temperature Problem (3022)
Patient Problem No Information (3190)
Event Date 01/29/2018
Event Type  malfunction  
Event Description
Iabp cardiosave hybrid. The machine would not print a strip. The door to the strip paper was hot to touch. When examined the paper appeared burned on one end and was black. Device under service agreement with manufacturer. Oem came in and inspected unit and performed necessary repairs. Manufacturer response for iap cardiosave hybrid, information not available (per site reporter) : repaired the machine.
 
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Brand NameCARDIOSAVE
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP.
1300 macarthur blvd
mahwah NJ 07430
MDR Report Key7713534
MDR Text Key114842179
Report Number7713534
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 Risk Manager
Type of Report Initial
Report Date 07/19/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/24/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/19/2018
Event Location Hospital
Date Report to Manufacturer07/24/2018
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? No
Type of Device Usage

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