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Adverse Event Report

DATASCOPE CORP. SYSTEM 98 IABP   back to search results
Model Number SYSTEM 98
Event Date 03/07/2001
Event Type  Malfunction  
Event Description

The customer reported that while the unit was in use on a patient, the unit intermittently experienced ecg loss. The pt was switched to another unit and therapy was continued. No pt injury was reported.

 
Manufacturer Narrative

The co rep replaced the ecg cable assembly and the front end pc board. The unit was tested to factory spec. It functioned normally and was returned to the customer.

 
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Brand NameSYSTEM 98
Type of DeviceIABP
Baseline Brand NameSYSTEM 98
Baseline Generic NameIABP
Baseline Catalogue Number0998-00-0446-XX
Baseline Model NumberSYSTEM 98
Baseline Device FamilyINTRA-AORTIC BALLOON PUMP
Baseline Device 510(K) NumberK922235
Baseline Device PMA Number
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)NA
Date First Marketed07/24/1998
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 Key322349
MDR Report Key332975
Event Key313378
Report Number2221819-2001-00055
Device Sequence Number1
Product CodeDSP
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other
Remedial Action Repair
Type of Report Initial
Report Date 03/07/2001
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/09/2001
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device MODEL NumberSYSTEM 98
Device Catalogue Number0998-00-0446-XX
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received03/07/2001
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/01/1999
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 06, 2009

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