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Adverse Event Report

DATASCOPE CORP. SYSTEM 97 IABP   back to search results
Model Number SYSTEM 97
Event Date 04/23/2000
Event Type  Malfunction  
Event Description

The customer reported that while the unit was in use on a pt, the unit failed to autofill. The pt was switched to another unit and therapy was continued. No pt injury was reported.

 
Manufacturer Narrative

The co rep observed that the volume cylinder failed to empty; the fill port luer fitting was broken; the helium tank valve knob was missing the ring that held the chain to the yoke bolt/knob. The co rep replaced the luer fitting, air cylinder and the helium tank valve knob. The unit was tested to factory spec. 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.
580 winters ave.
paramus NJ 07652
Manufacturer (Section D)
DATASCOPE CORP.
580 winters ave.
paramus NJ 07652
Manufacturer Contact
nicole archer
580 winters ave.
paramus , NJ 07652
(201) 967 -6911
Device Event Key268206
MDR Report Key277099
Event Key259826
Report Number2221819-2000-00144
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 04/24/2000
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/09/2000
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 Received04/24/2000
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 February 28, 2009

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