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U.S. Department of Health and Human Services

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

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DATASCOPE CORP. CARDIOSAVE RESCUE SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number 0998-00-0800-83
Device Problems Operating System Becomes Nonfunctional (2996); Therapeutic or Diagnostic Output Failure (3023)
Patient Problem Insufficient Information (4580)
Event Date 08/10/2020
Event Type  malfunction  
Event Description
Intra-aortic balloon pump (iabp) screen froze and pump stopped working. Manufacturer response for iabp, cardiosave (per site reporter).
 
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Brand NameCARDIOSAVE RESCUE
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP.
1300 macarthur blvd
mahwah NJ 07430
MDR Report Key10605579
MDR Text Key209143094
Report Number10605579
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 09/16/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/30/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number0998-00-0800-83
Device Catalogue Number0998-00-0800-83
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/16/2020
Device Age4 YR
Event Location Hospital
Date Report to Manufacturer09/30/2020
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 Unkown

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