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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD UNKNOWN INTRA-AORTIC BALLOON SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE CORP. - FAIRFIELD UNKNOWN INTRA-AORTIC BALLOON SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number UNKNOWN
Device Problems Filling Problem (1233); Gas Leak (2946)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/17/2021
Event Type  malfunction  
Manufacturer Narrative
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, the console would not resume and indicated that there was an autofill failure as well as gas loss. There was no blood seen in the helium tubing and no visible kinks. At this point, the console had been in stand-by without pumping for 25 minutes. The iab had been in the patient for over a week and the patient was scheduled for transplant later that morning. The customer swapped out the console but the same issue occurred. The customer was advised to drop the augmentation and press the "fill" key, but this did not resolve the issue. It was noted that the patient was stable and heparinized. A chest x-ray was ordered and the cath lab was called for possible removal/ replacement. As the stand-by time was nearing 30 minutes, the customer was reminded that it is not recommended to resume after the 30 minute mark. The customer stated they will discuss with the physician as to removing and/or replacing the iab. There was no patient harm or adverse event reported.
 
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Brand NameUNKNOWN INTRA-AORTIC BALLOON
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 Key12586696
MDR Text Key275196244
Report Number2248146-2021-00658
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 10/06/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/06/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
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 Received09/17/2021
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

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