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U.S. Department of Health and Human Services

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

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DATASCOPE CORP. - FAIRFIELD TRANS-RAY PLUS 7.5 FR. 40CC SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0684-00-0605
Device Problems Difficult to Insert (1316); Unraveled Material (1664)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/11/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4). 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. Complaint record id # (b)(4).
 
Event Description
It was reported that during intra-aortic balloon (iab) therapy, insertion of the iab became difficult due to unfurled membrane of the iab. A new iab was inserted successfully. There was no reported injury to the patient.
 
Manufacturer Narrative
Changed device available for eval from yes to no. 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. Complaint record # (b)(4).
 
Event Description
It was reported that during intra-aortic balloon (iab) therapy, insertion of the iab became difficult due to unfurled membrane of the iab. A new iab was inserted successfully. There was no reported injury to the patient.
 
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Brand NameTRANS-RAY PLUS 7.5 FR. 40CC
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - FAIRFIELD
15 law drive
fairfield NJ 07004
MDR Report Key9774509
MDR Text Key186142551
Report Number2248146-2020-00127
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,Followup
Report Date 03/31/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/02/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/10/2020
Device Catalogue Number0684-00-0605
Device Lot Number3000047040
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Event Location No Information
Date Manufacturer Received03/30/2020
Is This a Reprocessed and Reused Single-Use Device? No

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