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Adverse Event Report

DATASCOPE CORP. SYSTEM 98 IABP   back to search results
Model Number SYSTEM 98
Event Date 02/18/2001
Event Type  Malfunction  
Event Description

During an in-service training session, the co rep observed that the unit failed the safety disk leak test.

 
Manufacturer Narrative

The co rep observed that the unit was leaking 11 mm hg in the third section of the test. The co rep replaced the safety disk and the crm. The unit was tested to factory spec. It functioned normally and was returned to the customer.

 
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Brand NameSYSTEM 98
Type of DeviceIABP
Baseline Brand NameSYSTEM 98
Baseline Generic NameIABP
Baseline Catalogue Number0998-00-0446-XX
Baseline Model NumberSYSTEM 98
Baseline Device FamilyINTRA-AORTIC BALLOON PUMP
Baseline Device 510(K) NumberK922235
Baseline Device PMA Number
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)NA
Date First Marketed07/24/1998
Manufacturer (Section F)
DATASCOPE CORP.
800 macarthur blvd.
mahwah NJ 07430 0619
Manufacturer (Section D)
DATASCOPE CORP.
800 macarthur blvd.
mahwah NJ 07430 0619
Manufacturer Contact
nicole archer
800 macarthur boulevard
mahwah , NJ 07430-0619
(201) 995 -8406
Device Event Key309850
MDR Report Key320324
Event Key301257
Report Number2221819-2001-00045
Device Sequence Number1
Product CodeDSP
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other
Remedial Action Repair
Type of Report Initial
Report Date 02/21/2001
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/09/2001
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device MODEL NumberSYSTEM 98
Device Catalogue Number0998-00-0446-XX
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received02/21/2001
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/01/2000
Is The Device Single Use? No
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Reuse

Database last updated on January 30, 2009

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