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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 Problems Filling Problem (1233); Leak/Splash (1354)
Patient Problem High Blood Pressure/ Hypertension (1908)
Event Date 04/18/2021
Event Type  Injury  
Manufacturer Narrative
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 intra-aortic balloon (iab) therapy, the intra-aortic balloon pump (iabp) would not power on and could not fill the catheter system. The patient was receiving iab therapy, which was working great until 0145 when the iabp generated an alarm. The staff went into the patient's room to check the iabp and observed blood throughout the iabp tubing. A minute later, the iabp generated a system failure alarm and turned off. The doctor was informed and cardiology was paged. By 3 am the cardiology doctor was at bedside and went to pull out the iab, but the patient's systolic blood pressure (sbp) was a little high (160-170s). The patient was administered two doses of hydralazine. The doctor then disconnected the iab. Per the customer, end user ran the machine until a system failure shutdown was present caused by continued use in which blood contamination spilled onto multiple internal boards. A separate report has been submitted for the iabp under mfg report number 2249723-2021-01008.
 
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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
dorota wolpiuk
15 law drive
fairfield, NJ 
MDR Report Key11826101
MDR Text Key250748912
Report Number2248146-2021-00310
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 company representative,health
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 05/13/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/14/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
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 Received04/19/2021
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 05/14/2021 Patient Sequence Number: 1
Treatment
CARDIOSAVE / CA234851I3.
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