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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD SENSATION PLUS 8FR. 50CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE CORP. - FAIRFIELD SENSATION PLUS 8FR. 50CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number 0684-00-0576-01
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Death (1802)
Event Date 10/12/2020
Event Type  Death  
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. There was no reported malfunction. All the failure modes are addressed in the risk file. No labeling review can be completed as there was no reported malfunction. There were no crf/capa/scar/nmcr identified for "no reported malfunction". The investigation does not indicate that the device was inadvertently released as non-conforming or an adulterated product or was a counterfeit. The complaint history review did not identify an adverse trend (increase in number of complaints over past three (3) months). Based on the rational provided above, no escalation to the capa process is required. Reference complaint # (b)(4). Device not returned.
 
Event Description
It was reported that a patient death occurred following a coronary artery bypass graft (cabg) and aortic valve replacement(avr). Customer states that the utilized device was in use and could not elaborate on further details. Customer stated that patient had chronic atrial fibrillation, ventricular tachycardia(vtac) and needed right heart support. There was no reported malfunction on the intra-aortic balloon (iab). The facility does not attribute the death to the intra-aortic balloon (iab).
 
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Brand NameSENSATION PLUS 8FR. 50CC IAB
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - FAIRFIELD
15 law drive
fairfield NJ 07004
Manufacturer (Section G)
DATASCOPE CORP. - FAIRFIELD
15 law drive
fairfield NJ 07004
Manufacturer Contact
dorota wolpiuk
15 law drive
fairfield, NJ 07004
MDR Report Key10722391
MDR Text Key212675660
Report Number2248146-2020-00555
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
PMA/PMN Number
K112327
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 10/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/22/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/25/2022
Device Model Number0684-00-0576-01
Device Catalogue Number0684-00-0575
Device Lot Number3000092766
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/13/2020
Was Device Evaluated by Manufacturer? No
Date Device Manufactured03/25/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 10/22/2020 Patient Sequence Number: 1
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