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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE FAIRFIELD SENSATION IAB UNK FR UNK VOL SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE FAIRFIELD SENSATION IAB UNK FR UNK VOL SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number UNKNOWN
Device Problem Failure to Calibrate (2440)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/05/2018
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, while in the patient was in the operating room (or), the intra-aortic balloon pump (iabp) recognized fiber optic (fo) catheter but would not calibrate. Customer switched to fluid transducer pressure source. No error message was displayed. There was no reported injury to the patient.
 
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Brand NameSENSATION IAB UNK FR UNK 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 Key7920266
MDR Text Key122460155
Report Number2248146-2018-00560
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 Other Health Care Professional
Type of Report Initial
Report Date 09/28/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/28/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/06/2018
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

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