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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD UNKNOWN; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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DATASCOPE CORP. - FAIRFIELD UNKNOWN; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Lot Number UNKNOWN
Device Problem Moisture Damage (1405)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
(b)(6).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.(b)(4).
 
Event Description
It was reported that prior to use of the intra-aortic balloon (iab), 55 catheters appeared to have moisture inside the packaging.There was no patient involvement.This report is for #51 of the 55 devices.
 
Manufacturer Narrative
Initially reported; it was reported that prior to use of the intra-aortic balloon (iab), 55 catheters appeared to have moisture inside the packaging.There was no patient involvement.This report is for #51 of the 55 devices; corrected to; it was initially reported that there were 55 intra-aortic balloons (iab) catheters.This is being corrected to 41 catheters.Initial report of #51 of the 55 (this report) is being cancelled.Complaint # (b)(4), record id # (b)(4).
 
Event Description
It was initially reported that there were 55 intra-aortic balloons (iab) catheters.This is being corrected to 41 catheters.Initial report of #51 of the 55 (this report) is being cancelled.
 
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Brand Name
UNKNOWN
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - FAIRFIELD
15 law drive
fairfield NJ 07004
MDR Report Key8545195
MDR Text Key143584098
Report Number2248146-2019-00373
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 05/15/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/24/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Yes
Device Age YR
Date Manufacturer Received04/30/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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