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U.S. Department of Health and Human Services

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

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DATASCOPE CORP. - FAIRFIELD SENSATION PLUS 7.5FR. 40CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number 0684-00-0568-01
Device Problem Filling Problem (1233)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/14/2021
Event Type  malfunction  
Manufacturer Narrative
Complete event site name: (b)(6) heart hospital and heart centre. Complete event site address: (b)(4) event site postal code: (b)(6). Occupation: clinical technologist. The device has been returned to the factory and is being evaluated. A supplemental report will be submitted when the evaluation is completed. (b)(4).
 
Event Description
It was reported that after approximately 10 minutes of intra-aortic balloon (iab) therapy, the console generated a gas gain in iab circuit alarm as well as an autofill failure alarm. Troubleshooting was performed. All connections were checked, the "iab fill" key was used, and calibration was done, but every time the autofill failure alarm was generated. The patient was unstable and a decision was made to change the iab. A new iab was inserted and it worked properly without any alarms. There was no patient harm or adverse event reported.
 
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Brand NameSENSATION PLUS 7.5FR. 40CC 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 Key12624184
MDR Text Key276165167
Report Number2248146-2021-00665
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeSF
PMA/PMN Number
K122628
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/13/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number0684-00-0568-01
Device Catalogue Number0684-00-0567
Device Lot Number3000096709
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/07/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/19/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/21/2019
Is the Device Single Use? Yes
Type of Device Usage Initial

Patient Treatment Data
Date Received: 10/13/2021 Patient Sequence Number: 1
Treatment
CARDIOSAVE.
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