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Adverse Event Report

DATASCOPE CORP. SYSTEM 97 IABP   back to search results
Model Number SYSTEM 97
Event Date 01/05/2001
Event Type  Death   Patient Outcome  Death;
Event Description

The customer reported that while the unit was in use on a patient that was fully atrio-ventricular paced, the unit generated a "no trigger" alarm; spikes were no longer being enhanced. The customer was unable to trigger using pressure. The patient went into atrial fibrillation. After being stabilized, the pt was switched to another unit and therapy was continued. The customer was able to trigger using the atrio-ventricular pacer. The patient expired the next day.

 
Manufacturer Narrative

The company representative was unable to duplicate the reported problem. 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 boulevard
mahwah NJ 07430 0619
Manufacturer (Section D)
DATASCOPE CORP.
800 macarthur boulevard
mahwah NJ 07430 0619
Manufacturer Contact
nicole archer
800 macarthur boulevard
mahwah , NJ 07430-0619
(201) 995 -8406
Device Event Key309491
MDR Report Key319963
Event Key300891
Report Number2221819-2001-00014
Device Sequence Number1
Product CodeDSP
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Nurse
Remedial Action Inspection
Type of Report Initial
Report Date 01/08/2001
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? Yes
Is This A Product Problem Report? No
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 Received01/08/2001
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/01/1994
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 January 30, 2009

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