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U.S. Department of Health and Human Services

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

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DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID TYPE B PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number N/A
Device Problem Gas Leak (2946)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/06/2020
Event Type  malfunction  
Manufacturer Narrative
At this time, the customer has not requested getinge to evaluate the iabp. It was reported that the facility's clinical engineering biomed would be performing the inspection and repair of the iabp unit. Additional information has been requested from the customer. If the information is provided, it will be reported accordingly.
 
Event Description
It was reported that the cardiosave intra-aortic balloon pump (iabp) had a helium leak in the cart. In addition, customer reported that the helium tank was changed twice and within minutes the tanks have both shown empty. Customer stated that the tank is "open", there is one o ring washer, and no leaks, hissing, alarms shown. It was advised to replaced the iabp unit and to report this pump to clinical engineering. It is unknown under which circumstances this event occurred; however no adverse event was reported.
 
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Brand NameCARDIOSAVE HYBRID TYPE B 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 Key10924399
MDR Text Key221290078
Report Number2249723-2020-02036
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 03/03/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/30/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number0998-00-0800-53
Device Lot NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/03/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured12/01/2015
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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