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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 Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 12/10/2021
Event Type  Death  
Event Description
It was reported that during use on a patient, the cardiosave intra-aortic balloon pump (iabp) displayed "power up test code #4 fails¿ message. The next pump started and provided therapy for less than a minute. During that time, a restriction alarm occurred and pumping was resumed via the ¿start¿ key. The pump then alarmed with an ¿internal communication failure¿ message. The iab was inserted emergently in the emergency department to a critically ill patient. At startup of these pumps, the critical patient was also being given chest compressions by a mechanical cpr device. The patient did not survive. The physician has verbalized that the "malfunction of the iabp did not change the patient outcome". The customer did not wish to participate in giving iab or patient information for this event. This reported is for the iab with no reported malfunction. Two separate reports will be submitted for the 2 involved cardiosave intra-aortic balloon pumps(iabps).
 
Manufacturer Narrative
The device will not be returned to the manufacturer so we are unable to complete an evaluation. If provided we will send a supplemental report with our additional findings. Complaint record id # (b)(4).
 
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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
Manufacturer (Section G)
DATASCOPE CORP. - FAIRFIELD
15 law drive
fairfield NJ
Manufacturer Contact
brian schaeffer
15 law drive
fairfield, NJ 
MDR Report Key13130401
MDR Text Key283077450
Report Number2248146-2021-00896
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/31/2021
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
Date Manufacturer Received12/10/2021
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Type of Device Usage

Patient Treatment Data
Date Received: 12/31/2021 Patient Sequence Number: 1
Treatment
CARDIOSAVE / (B)(4).CARDIOSAVE / (B)(4).
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