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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. 35CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE CORP. - FAIRFIELD TRANS-RAY PLUS 7.5 FR. 35CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0684-00-0604
Device Problems Difficult to Insert (1316); Failure to Calibrate (2440)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/04/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(6). 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. (b)(4).
 
Event Description
It was reported that the intra-aortic balloon (iab) had been difficult to insert. Once the iab was inserted, the customer began pumping, however, they were unable to calibrate. The console then generated a check iab catheter alarm. The iab was removed and replaced with a new one. There was no patient harm or adverse event reported.
 
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Brand NameTRANS-RAY PLUS 7.5 FR. 35CC IAB
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - FAIRFIELD
15 law drive
fairfield NJ
Manufacturer (Section G)
DATASCOPE CORP. - FAIRFIELD
15 law drive
fairfield NJ
Manufacturer Contact
brian schaeffer
15 law drive
fairfield, NJ 
MDR Report Key12689683
MDR Text Key278146877
Report Number2248146-2021-00692
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/25/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number0684-00-0604
Device Lot Number3000128507
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received12/02/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured07/31/2020
Is the Device Single Use? Yes
Type of Device Usage Initial

Patient Treatment Data
Date Received: 10/25/2021 Patient Sequence Number: 1
Treatment
UNKNOWN.
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