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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD YAMATO PLUS-R 7.5FR. 30CC; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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DATASCOPE CORP. - FAIRFIELD YAMATO PLUS-R 7.5FR. 30CC; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0684-00-0549-01
Device Problems Filling Problem (1233); Defective Component (2292)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/16/2020
Event Type  malfunction  
Manufacturer Narrative
The product has been returned to the manufacturer, but is pending investigation.Once the investigation is completed a supplemental report with our findings will be submitted.Complaint record id # (b)(4).
 
Event Description
It was reported during intra-aortic balloon(iab) therapy in a patient with acute myocardial infarction (ami), the console generated an autofill failure alarm because the connector of the extension cable is damaged and treatment was unable to be started.The extension cable was replaced to start therapy.There was no reported injury to the patient.
 
Manufacturer Narrative
'lot #.' changed from 3000083328 to 3000072337.The extender tubing was returned.No blood was visible.A portion of the tip from the male luer on the extender tubing was found to be cut from the leur and not returned.No leaks or additional damage was found on the tubing.The evaluation confirms the reported problems.We are unable to determine when this may have occurred.A device and lot history record review was completed for the reported product.No nonconformances were found that are considered to be related to the event.Complaint record # (b)(4).
 
Event Description
It was reported during intra-aortic balloon(iab) therapy in a patient with acute myocardial infarction (ami), the console generated an autofill failure alarm because the connector of the extension cable is damaged and treatment was unable to be started.The extension cable was replaced to start therapy.There was no reported injury to the patient.
 
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Brand Name
YAMATO PLUS-R 7.5FR. 30CC
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - FAIRFIELD
15 law drive
fairfield NJ 07004
MDR Report Key9664238
MDR Text Key187908055
Report Number2248146-2020-00067
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 03/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/04/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/07/2021
Device Catalogue Number0684-00-0549-01
Device Lot Number3000072337
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/03/2020
Was the Report Sent to FDA? Yes
Date Manufacturer Received03/09/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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