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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD SENSATION PLUS 7.5FR. 40CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE CORP. - FAIRFIELD SENSATION PLUS 7.5FR. 40CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0684-00-0567
Device Problem Incorrect, Inadequate or Imprecise Resultor Readings (1535)
Patient Problem High Blood Pressure/ Hypertension (1908)
Event Date 02/12/2019
Event Type  malfunction  
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 that during intra-aortic balloon (iab) therapy, the blood pressure reading was much higher than other sources. Aortic pressure and cuff pressure were matched with the balloon off, but the intra-aortic balloon pump (iabp) read 50-60 points higher. The patient was transferred with receiving facilities pump and no other issues were noted. No adverse event, patient injury or death was reported.
 
Event Description
It was reported that during intra-aortic balloon (iab) therapy, the blood pressure reading was much higher than other sources. Aortic pressure and cuff pressure were matched with the balloon off, but the intra-aortic balloon pump (iabp) read 50-60 points higher. The patient was transferred with receiving facilities pump and no other issues were noted. No adverse event, patient injury or death was reported.
 
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).
 
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Brand NameSENSATION PLUS 7.5FR. 40CC IAB
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - FAIRFIELD
15 law drive
fairfield NJ 07004
MDR Report Key8408804
MDR Text Key138551432
Report Number2248146-2019-00194
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
PMA/PMN Number
K122628
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 04/04/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/11/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number0684-00-0567
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Device Age YR
Event Location No Information
Date Manufacturer Received04/01/2019
Is This a Reprocessed and Reused Single-Use Device? No

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