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U.S. Department of Health and Human Services

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

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DATASCOPE FAIRFIELD SENSATION PLUS IAB UNKNOWN VOL. SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number UNKNOWN
Device Problem Battery Problem (2885)
Patient Problem No Information (3190)
Event Date 01/25/2018
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
There was no reported malfunction of the intra-aortic balloon (iab) during therapy. As per the ccl(cardiac cath lab) nurse: the balloon pump was started at 2333 in the cath lab. The patient left the cath lab with ems(emergency medical services) and the nurse at 0010 in the transport mode. They were en route to a different site and had to initiate cpr(cardiopulmonary resuscitation) about 3 minutes after leaving the facility. After approximately 10 minutes of not getting a pulse back, they made the decision to return to the customer er(emergency room) rather than continue with the transport. They arrived back at their er at 0053 and prior to leaving on the way back to the other site, the nurse noted the battery to be low. So the cardiologist went to the heart center and brought the console to the er and they placed the pump back into the console for transport. They left the er for the 2nd time at 0136. Before they could get the unit plugged into the ambulance the battery died on the balloon pump. It was off pump for approximately 5 minutes while waiting for the pump to power back up and to begin pumping again. Upon initiation of balloon pump restarting, patients systolic bp(blood pressure) was 60. After 5 minutes of balloon pump functioning, patients augmented bp(blood pressure) was 110. Patient was successfully transported to the different site with balloon pump with no further issues.
 
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Brand NameSENSATION PLUS IAB UNKNOWN VOL.
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE FAIRFIELD
15 law drive
fairfield NJ 07004
Manufacturer (Section G)
DATASCOPE FAIRFIELD
15 law drive
fairfield NJ 07004
Manufacturer Contact
15 law drive
fairfield, NJ 07004
MDR Report Key7476735
MDR Text Key107069072
Report Number2248146-2018-00295
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
Type of Report Initial
Report Date 04/27/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/01/2018
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? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/06/2018
Was Device Evaluated by Manufacturer? No Answer Provided
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: 05/01/2018 Patient Sequence Number: 1
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