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U.S. Department of Health and Human Services

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

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DATASCOPE CORP. - FAIRFIELD MEGA 7.5FR. 40CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number 0684-00-0295-01
Device Problems Filling Problem (1233); Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/04/2021
Event Type  malfunction  
Manufacturer Narrative
Complete event site name: (b)(6) medical center (b)(6) division. 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 after three days of intra-aortic balloon (iab) therapy, the customer was helping the patient out of bed and the console generated a leak in circuit alarm several times and then an auto-fill failure alarm. The insertion was reported to be axillary, which is not the method described in the device instructions for use. There was no blood in the tubing and chest films did not show any internal kinks. The customer attempted several auto-fills and was able to get the console pumping again. However, several minutes later the console once again indicated that there was a leak. The customer tried to auto-fill again, but it had failed. The physician, who was at the bedside, reported that there was a severe kink where they had "looped" the helium tubing the secure it to the patient's upper extremity. The physician removed the kink, but still could not fill the iab. It was then decided to replace the iab. The patient was stable at this point. There was no patient harm or adverse event reported.
 
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Brand NameMEGA 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
dorota wolpiuk
15 law drive
fairfield, NJ 
MDR Report Key11876605
MDR Text Key252393172
Report Number2248146-2021-00332
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K120868
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/01/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/25/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number0684-00-0295-01
Device Catalogue Number0684-00-0293
Device Lot Number3000116949
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/01/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured03/13/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

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