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U.S. Department of Health and Human Services

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

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DATASCOPE CORP. - FAIRFIELD UNKNOWN IAB 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 Low Blood Pressure/ Hypotension (1914)
Event Date 03/26/2020
Event Type  Injury  
Manufacturer Narrative
The device has not been returned to the manufacturer so we are unable to complete an evaluation. If provided we will send a supplemental report with our additional findings. (b)(4).
 
Event Description
It was reported during cardiosave intra-aortic balloon pump(iabp) therapy, the device spontaneously failed while in operation on a critical care patient. The intra-aorta balloon pump (iabp) suddenly shutdown. This spontaneous fail is a duplicate of an occurrence during the preventive maintenance battery test on a full battery 5 weeks ago. After the preventive maintenance incident, the customer spoke with getinge tech support and completed 2 subsequent 60 minute discharge tests on the battery with no errors, per their instructions. As all other tests passed during the preventive maintenance (pm), this occurred only during the battery test at the end of the pm function, calibration and operation tests. Per the nurse the unit was plugged in at the time of failure. This battery was fully charged both times and failed with 25 to 35 minutes of use. Patient lost blood pressure with significant desaturation. There was no reported malfunction on the intra-aortic balloon(iab).
 
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Brand NameUNKNOWN IAB
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 Key9979053
MDR Text Key188530708
Report Number2248146-2020-00233
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 04/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/20/2020
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 Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Event Location No Information
Date Manufacturer Received03/30/2020
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

Patient Treatment Data
Date Received: 04/20/2020 Patient Sequence Number: 1
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