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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD MEGA 8FR. 50CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE CORP. - FAIRFIELD MEGA 8FR. 50CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number 0684-00-0296-01
Device Problem Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/09/2021
Event Type  malfunction  
Manufacturer Narrative
The initial reporter named in block is a getinge employee whose contact details are: (b)(6); which differs from that of the event site. The product has been returned to the manufacturer, but is pending investigation. Once the investigation is completed a supplemental report with our findings will be submitted. Complaint record id # (b)(4).
 
Event Description
During the investigation of the returned intra-aortic balloon (iab) involved under mfg report number 2248146-2021-00351, a kink was found that was unrelated to the reported silicone migration (condensation) failure mode. There was no patient involvement.
 
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Brand NameMEGA 8FR. 50CC 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
brian schaeffer
15 law drive
fairfield, NJ 
MDR Report Key12567920
MDR Text Key274450480
Report Number2248146-2021-00642
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K091449
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/13/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/04/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number0684-00-0296-01
Device Catalogue Number0684-00-0497
Device Lot Number3000131134
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/13/2021
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/13/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/15/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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