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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE FAIRFIELD SENSATION PLUS UNK VOL.; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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DATASCOPE FAIRFIELD SENSATION PLUS UNK VOL.; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Low Blood Pressure/ Hypotension (1914); Ischemia (1942)
Event Date 01/19/2017
Event Type  Injury  
Manufacturer Narrative
The product is not promised for return.As a result, we are unable to complete an evaluation.A supplemental report will be provided if new information becomes available.(b)(4).
 
Event Description
Patient developed ischemic bowel during iabp support.Required balloon removal and bowel resection unknown if balloon factor.Patient was also severely hypotensive and hypo perfused with history of colitis.
 
Manufacturer Narrative
(b)(4).
 
Event Description
Patient developed ischemic bowel during iabp support.Required balloon removal and bowel resection unknown if balloon factor.Patient was also severely hypotensive and hypo perfused with history of colitis.
 
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Brand Name
SENSATION PLUS UNK VOL.
Type of Device
SYSTEM, 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 Key6326861
MDR Text Key67280732
Report Number2248146-2017-00011
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K112372
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 04/04/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/13/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Device AgeYR
Date Manufacturer Received01/25/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age83 YR
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