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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 Break (1069)
Patient Problem No Information (3190)
Event Type  malfunction  
Manufacturer Narrative
The production device history record (dhr) for this intra-aortic balloon pump (iabp) is not required to be reviewed per getinge standard operating procedure since the iabp was manufactured more than a year before the date of event.A getinge field service engineer (fse) evaluated the iabp unit and replaced the cable assembly for the fiber optic extension.The fse ran the fiber optic sensor tests and the unit passed.Subsequently, the unit failed the pneumatic interface module(pim) tests.The fse discovered that the top right pim screw was broken in the threaded hole preventing good seal.The unit was returned to the customer but not cleared for clinical use.A supplemental report will be submitted when additional information is provided.
 
Event Description
It was reported by the customer the cardiosave intra-aortic balloon pump (iabp) fiber-optic connector is pushed in and safety chamber screw is missing.It is unknown under which circumstances this event occurred.It is also unknown if there was a patient involvement.However, there was no adverse event reported.
 
Event Description
It was reported by the customer the cardiosave intra-aortic balloon pump (iabp) fiber-optic connector is pushed in and safety chamber screw is missing.It is unknown under which circumstances this event occurred.It is also unknown if there was a patient involvement.However, there was no adverse event reported.
 
Manufacturer Narrative
The service territory manager (stm) reported that after evaluation at the depot it was determined that the unit is not repairable because the defect is on the main chassis of the console that is not available as a repair part.The iabp is not safe to be put back into service.
 
Event Description
It was reported by the customer the cardiosave intra-aortic balloon pump (iabp) fiber-optic connector is pushed in and safety chamber screw is missing.It is unknown under which circumstances this event occurred.It is also unknown if there was a patient involvement.However, there was no adverse event reported.
 
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Brand Name
CARDIOSAVE HYBRID TYPE B PLUG
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ 07430
MDR Report Key10014575
MDR Text Key193127495
Report Number2249723-2020-00683
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
PMA/PMN Number
K112372
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup,Followup
Report Date 06/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/30/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberN/A
Device Catalogue Number0998-00-0800-53
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Date Manufacturer Received05/13/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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