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Adverse Event Report

DATASCOPE CORP. SYSTEM 97E IABP   back to search results
Model Number SYSTEM 97E
Event Date 10/02/2000
Event Type  Malfunction  
Event Description

The customer reported that while the unit was in use on a pt, the unit failed to "zero the pressure" or generate a pressure display. The pt was switched to another unit and therapy was continued. No pt injury was reported.

 
Manufacturer Narrative

The co rep replaced the input (csd box) assembly. The unit was tested to factory specification. It functioned normally and was returned to the customer.

 
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Brand NameSYSTEM 97E
Type of DeviceIABP
Baseline Brand NameSYSTEM 97E
Baseline Generic NameIABP
Baseline Catalogue Number0998-00-0142-X
Baseline Model NumberSYSTEM 97E
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 blvd.
mahwah , NJ 07430-0619
(201) 995 -8406
Device Event Key294814
MDR Report Key304641
Event Key286254
Report Number2221819-2000-00282
Device Sequence Number1
Product CodeDSP
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other
Remedial Action Repair
Type of Report Initial
Report Date 10/03/2000
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/09/2000
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device MODEL NumberSYSTEM 97E
Device Catalogue Number0998-00-0142-XX
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received10/02/2000
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/01/1994
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 February 28, 2009

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