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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD TRANSRAY PLUS 7.5FR. 35CC SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE CORP. - FAIRFIELD TRANSRAY PLUS 7.5FR. 35CC SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0684-00-0604
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Death (1802)
Event Date 06/17/2020
Event Type  Death  
Manufacturer Narrative
Event site postal code: (b)(6). The device was not returned and could not be evaluated. We are unable to confirm the reported event. If new information becomes available, a supplemental report will be submitted. Complaint # (b)(4).
 
Event Description
It was reported the during use on patient the cardiosave intra-aortic balloon pump (iabp) unit became black unexpectedly and the pumping stopped and also an alarm was emitting. The iabp was re-booted and iabp therapy was continued. This iabp unit was used on the patient with acute myocardial infarction(ami). The patient¿s condition was noted to be deteriorated already with premature ventricular contraction (pvc) and ventricular fibrillation (vf). The patient was expired on the same day. The relationship of both the event and the iabp unit to the patient¿s death was unrelated. There was no reported malfunction on the iab. A separate report for the iabp has been submitted under mfg # 2249723-2020-01436.
 
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Brand NameTRANSRAY PLUS 7.5FR. 35CC
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - FAIRFIELD
15 law drive
fairfield NJ 07004
Manufacturer (Section G)
DATASCOPE CORP. - FAIRFIELD
15 law drive
fairfield NJ 07004
Manufacturer Contact
dorota wolpiuk
15 law drive
fairfield, NJ 07004
MDR Report Key10514546
MDR Text Key206334938
Report Number2248146-2020-00460
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 12/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/10/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number0684-00-0604
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/07/2020
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/10/2020 Patient Sequence Number: 1
Treatment
CARDIOSAVE / CH215828H5
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