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Adverse Event Report

DATASCOPE CORP. SYSTEM 97 IABP   back to search results
Model Number SYSTEM 97
Event Date 02/19/2002
Event Type  Malfunction  
Event Description

The customer reported that while the unit was in use on a patient, the unit shutdown when the autofill button was pressed. The patient was switched to another unit and therapy was continued. No patient injury was reported.

 
Manufacturer Narrative

The company representative evaluated the unit and isolated the power supply as the cause of the failure.

 
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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
candy beck
800 macarthur blvd
mahwah , NJ 07430-0619
(201) 995 -8045
Device Event Key370915
MDR Report Key381865
Event Key360519
Report Number2221819-2002-00015
Device Sequence Number1
Product CodeDSP
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation BIOMEDICAL ENGINEER
Remedial Action Inspection
Type of Report Initial
Report Date 02/19/2002
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/11/2002
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? No Answer Provided
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
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? Unknown
Type of Device Usage Reuse

Database last updated on January 30, 2009

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