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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID DOMESTIC SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID DOMESTIC SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number N/A
Device Problem Gas Leak (2946)
Patient Problem No Patient Involvement (2645)
Event Date 12/10/2020
Event Type  malfunction  
Manufacturer Narrative
A getinge field service engineer (fse) was dispatched to evaluate the iabp unit and found torn o-ring on male plug that attaches helium pressure from rescue to cart. The fse replaced the o-ring and performed all functional and safety checks to meet factory specifications. Unit passed all functional and safety test per factory specifications. The iabp was then released to the customer and cleared for clinical service.
 
Event Description
It was reported that during pre-use check, when unit was plugged into cart, the cardiosave intra-aortic balloon pump (iabp) had a helium leak and a display issue. There was no patient involvement, and no adverse event reported.
 
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Brand NameCARDIOSAVE HYBRID DOMESTIC
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ 07430
Manufacturer (Section G)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ 07430
Manufacturer Contact
dorota wolpiuk
1300 macarthur blvd
mahwah, NJ 07430
MDR Report Key11103096
MDR Text Key226052552
Report Number2249723-2020-02272
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K112372
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 01/26/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/31/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Device Catalogue Number0998-00-0800-53
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/28/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/01/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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