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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 Tachycardia (2095)
Event Date 12/26/2019
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. Complaint record id#: (b)(4).
 
Event Description
It was reported that during use on a patient an overheat alarm occurred on a intra-aortic balloon pump (iabp) and pumping was stopped. Patient who started using intra-aortic balloon pump (iabp) on (b)(6), 2019 at 13:00, said that at night, heart rate 130bpm to 150bpm and tachycardia was present and the situation was unstable. At around 6:30 am on (b)(6), 2019, a nurse was treating the patient, and the intra-aortic balloon pump (iabp) sounded an alarm, the nurse saw the message "overheat" and confirmed that pumping was not being performed. The nurse called the doctor and pressed the start button, but it did not work and contacted clinical engineering and made trial and error. Six minutes later, the power was turned on and off and the start button was pressed to resume pumping. V-a ecmo was used. After about 8am, the customer decided to exchange with intra-aortic balloon pump (iabp) after consulting with day shift staff. A replacement intra-aortic balloon pump (iabp) was brought in for intra-aortic balloon pump (iabp) at 12:00 and checked the situation and exchanged it for the target machine. There was no reported malfunction on the intra-aortic balloon (iab) used.
 
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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 Key9621968
MDR Text Key185519427
Report Number2248146-2020-00043
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 03/04/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/23/2020
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
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Event Location No Information
Date Manufacturer Received03/04/2020
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: 01/23/2020 Patient Sequence Number: 1
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