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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD SENSATION 7FR. 40CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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DATASCOPE CORP. - FAIRFIELD SENSATION 7FR. 40CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number 0684-00-0470-01
Device Problem Restricted Flow rate (1248)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/13/2020
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).Device not returned.
 
Event Description
It was reported that after approximately 2 days of intra-aortic balloon (iab) therapy, the console generated a catheter restriction alarm while the patient was sleeping.All troubleshooting efforts were unsuccessful, therefore, the customer removed the iab.There were no kinks noted in the iab.There was no patient harm or adverse event reported.
 
Event Description
It was reported that after approximately 2 days of intra-aortic balloon (iab) therapy, the console generated a catheter restriction alarm while the patient was sleeping.All troubleshooting efforts were unsuccessful, therefore, the customer removed the iab.There were no kinks noted in the iab.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.If provided we will send a supplemental report with our additional findings.The failure mode is addressed in the risk file and is operating within its risk profile.The ifu addresses the reported failure.There were no ncmrs identified which could cause or contribute to the reported failure.The investigation does not indicate that the device was inadvertently released as non-conforming or an adulterated product or was a counterfeit.The complaint history review did not identify an adverse trend (increase in number of complaints over past three (3) months).Based on the rational provided above, no escalation to the capa process is required.Reference complaint (b)(4).H3 other text : device not returned.
 
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Brand Name
SENSATION 7FR. 40CC IAB
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - FAIRFIELD
15 law drive
fairfield NJ 07004
MDR Report Key10785199
MDR Text Key214556538
Report Number2248146-2020-00581
Device Sequence Number1
Product Code DSP
UDI-Device Identifier10607567106779
UDI-Public10607567106779
Combination Product (y/n)N
PMA/PMN Number
K063525
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 03/25/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/04/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number0684-00-0470-01
Device Catalogue Number0684-00-0434
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Yes
Date Manufacturer Received03/25/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
CARDIOSAVE.; CARDIOSAVE
Patient Age84 YR
Patient Weight56
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