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U.S. Department of Health and Human Services

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

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DATASCOPE CORP. - MAHWAH UNKNOWN IABP SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Injury (2348)
Event Date 09/10/2020
Event Type  Injury  
Manufacturer Narrative
A company representative has advised that the customer has not alleged a malfunction of the iabp, and the pump model and serial number have not been provided. If additional information is provided, a supplemental report will be submitted.
 
Event Description
It was reported that while in use, blood was barely seen in the gas line of a datascope manufactured intra-aortic balloon pump (iabp). The iabp type is unknown. The iabp was then placed in stand-by mode 1. 5 hours prior to the intra-aortic balloon catheter (iabc) removal because the patient was heparinized. When the cardiologist attempted removal of the iabc, it was found to be entrapped, so it was necessary to remove it surgically. There was no reported malfunction of the iabp by the customer. The intra-aortic balloon catheter has been submitted under a separate manufacturer¿s report, reference report 2248146-2020-00517.
 
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Brand NameUNKNOWN IABP
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ 07430
Manufacturer (Section G)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ 07430
Manufacturer Contact
dorota wolpiuk
1300 macarthur blvd
mahwah, NJ 07430
MDR Report Key10616747
MDR Text Key209572211
Report Number2249723-2020-01598
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeFI
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/26/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/01/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Device Catalogue NumberUNKNOWN
Device Lot NumberN/A
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 Received09/30/2020
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 10/01/2020 Patient Sequence Number: 1
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