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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 Problems Filling Problem (1233); Difficult to Flush (1251)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/08/2021
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, an auto-fill failure occurred.The console was swapped out, but the same issue occurred.All connections were secure and the safety disc was in the correct position.There was no blood seen in the helium tubing.It was also reported that the iab would not aspirate blood or flush.The customer attempted to restart multiple times without success.The customer then considered the possibility of removing the iab.There was no patient harm or adverse event reported.
 
Event Description
It was reported that during intra-aortic balloon (iab) therapy, an auto-fill failure occurred.The console was swapped out, but the same issue occurred.All connections were secure and the safety disc was in the correct position.There was no blood seen in the helium tubing.It was also reported that the iab would not aspirate blood or flush.The customer attempted to restart multiple times without success.The customer then considered the possibility of removing the iab.There was no patient harm or adverse event reported.
 
Manufacturer Narrative
Correction to medical device ¿ problem code.Removing infusion or flow problem|difficult to flush||1251.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, an auto-fill failure occurred.The console was swapped out, but the same issue occurred.All connections were secure and the safety disc was in the correct position.There was no blood seen in the helium tubing.It was also reported that the iab would not aspirate blood or flush.The customer attempted to restart multiple times without success.The customer then considered the possibility of removing 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.Complaint record id # (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
MDR Report Key11589384
MDR Text Key246850289
Report Number2248146-2021-00200
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,Followup
Report Date 06/10/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/12/2022
Device Model Number0684-00-0470-01
Device Catalogue Number0684-00-0434
Device Lot Number3000108622
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 04/01/2021
Initial Date FDA Received03/30/2021
Supplement Dates Manufacturer Received04/01/2021
06/10/2021
Supplement Dates FDA Received04/22/2021
06/10/2021
Patient Sequence Number1
Patient Age66 YR
Patient Weight86
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