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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD UNKNOWN INTRA-AORTIC BALLOON SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE CORP. - FAIRFIELD UNKNOWN INTRA-AORTIC BALLOON SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number UNKNOWN
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Death (1802); Myocardial Infarction (1969); Cardiogenic Shock (2262)
Event Date 02/05/2021
Event Type  Death  
Manufacturer Narrative
Event site postal code - (b)(6). Initial reporter name - (b)(6) additional initial reporter information - (b)(6). The device was not returned and could not be evaluated. It was discarded by the user. We are unable to confirm the reported event. If new information becomes available, a supplemental report will be submitted. Complaint record id # (b)(4).
 
Event Description
It was reported that during use on a patient, the cardiosave intra-aortic balloon pump (iabp) alarmed. When the clinical user selected "help" a "unit overheating" message appeared. The intra-aortic balloon pump (iabp) was swapped for another to finish the procedure. Patient had expired due to poor prognosis. Immediate cause of death: cardiogenic shock. Antecedent causes: myocardial infarction. The patient went into cardiogenic shock, arrested, ventricular fibrillation (vf), defibrillated, pulseless electrical activity (pea) and cardiopulmonary resuscitation (cpr) x 10 minutes. A separate report will be submitted for the cardiosave intra-aortic balloon pump (iabp).
 
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Brand NameUNKNOWN INTRA-AORTIC BALLOON
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 Key11375939
MDR Text Key233434777
Report Number2248146-2021-00139
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/24/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/24/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNKNOWN
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 Received06/24/2021
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

Patient Treatment Data
Date Received: 02/24/2021 Patient Sequence Number: 1
Treatment
CARDIOSAVE / (B)(4)
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