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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD SENSATION PLUS 8FR. 50CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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DATASCOPE CORP. - FAIRFIELD SENSATION PLUS 8FR. 50CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number 0684-00-0576-01
Device Problems Inability to Auto-Fill (1044); Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/13/2021
Event Type  malfunction  
Manufacturer Narrative
The device has been returned to the factory and is being evaluated.A supplemental report will be submitted when the evaluation is completed.Complaint record id # (b)(4).
 
Event Description
It was reported that the customer had just inserted the intra-aortic balloon (iab) when the console indicated that there was an auto-fill failure.The customer attempted restarting and auto-filling again.There was no blood observed in the tubing and no visible kinks at that time.The helium tank was full and the valve was fully turned open.The customer was advised to use a new console or to remove that iab as it had been in standby for a while.It was later reported that the iab had been removed and a severe kink was discovered near the y-connector.There was no patient harm or adverse event reported.
 
Manufacturer Narrative
Correction: section a patient information sex changed from female to male.The device has been returned to the factory and is being evaluated.A supplemental report will be submitted when the evaluation is completed.Complaint record id # (b)(4).
 
Event Description
It was reported that the customer had just inserted the intra-aortic balloon (iab) when the console indicated that there was an auto-fill failure.The customer attempted restarting and auto-filling again.There was no blood observed in the tubing and no visible kinks at that time.The helium tank was full and the valve was fully turned open.The customer was advised to use a new console or to remove that iab as it had been in standby for a while.It was later reported that the iab had been removed and a severe kink was discovered near the y-connector.There was no patient harm or adverse event reported.
 
Manufacturer Narrative
The device has not been returned to the manufacturer so we are unable to complete an evaluation.Analysis of production (3331/213) - the device history records review concluded that there were no ncmrs, rework, or deviations documented for the reported lot/serial number.Based on the review results, it was determined that there is no relation between the manufacturing process and the reported failure.Historical data analysis (4109/213) - the review of the historical data was performed.Trend analysis (4110/213) - the overall complaint trend data for the period may-19 to apr-21 was reviewed.Communication/interviews: (4111/213) communication/interviews were performed to obtain all possible information.Reference complaint #(b)(4).
 
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Brand Name
SENSATION PLUS 8FR. 50CC IAB
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - FAIRFIELD
15 law drive
fairfield NJ
MDR Report Key11760210
MDR Text Key248449133
Report Number2248146-2021-00275
Device Sequence Number1
Product Code DSP
UDI-Device Identifier10607567108605
UDI-Public10607567108605
Combination Product (y/n)N
PMA/PMN Number
K112327
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup,Followup
Report Date 08/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/03/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/25/2022
Device Model Number0684-00-0576-01
Device Catalogue Number0684-00-0575
Device Lot Number3000092766
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/20/2021
Date Manufacturer Received08/11/2021
Patient Sequence Number1
Treatment
CARDIOSAVE / CH294554A9
Patient Age80 YR
Patient Weight65
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