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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID TYPE E/F PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID TYPE E/F PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number N/A
Device Problem Gas/Air Leak (2946)
Patient Problem No Patient Involvement (2645)
Event Date 12/10/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(6). A getinge field service engineer (fse) evaluated the iabp and replaced the helium regulator 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 a demonstration, the cardiosave intra- aortic balloon pump (iabp) had a helium leak at high pressure. There was no patient involvement, and no adverse event reported.
 
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Brand NameCARDIOSAVE HYBRID TYPE E/F PLUG
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 Key11103006
MDR Text Key226042951
Report Number2249723-2020-02270
Device Sequence Number1
Product Code DSP
UDI-Device Identifier10607567108414
UDI-Public10607567108414
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
K112372
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/15/2021
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? Yes
Device Operator Other
Device Model NumberN/A
Device Catalogue Number0998-00-0800-55
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/09/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/01/2019
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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