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Adverse Event Report

DATASCOPE CORP. SYSTEM 97 IABP   back to search results
Model Number SYSTEM 97
Event Date 08/06/2001
Event Type  Malfunction  
Event Description

During a preventive maintenance, the company representative observed that the unit's display was missing one column of pixels on the left hand side.

 
Manufacturer Narrative

The company representative replaced the plasma display and completed the preventive maintenance on the unit. The unit was tested to factory specification. It functioned normally and was returned to the customer.

 
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Brand NameSYSTEM 97
Type of DeviceIABP
Baseline Brand NameSYSTEM 97
Baseline Generic NameIABP
Baseline Catalogue Number0998-00-0104-XX
Baseline Model NumberSYSTEM 97
Baseline Device FamilySYSTEM 97
Baseline Device 510(K) NumberK922235
Baseline Device PMA Number
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)NA
Date First Marketed08/06/1993
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 Key340587
MDR Report Key351305
Event Key330931
Report Number2221819-2001-00186
Device Sequence Number1
Product CodeDSP
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation BIOMEDICAL ENGINEER
Remedial Action Repair
Type of Report Initial
Report Date 08/06/2001
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/07/2001
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device MODEL NumberSYSTEM 97
Device Catalogue Number0998-00-0104-XX
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received08/06/2001
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/01/1995
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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