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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 Problems No Display/Image (1183); Device Sensing Problem (2917)
Patient Problem No Patient Involvement (2645)
Event Date 02/26/2019
Event Type  malfunction  
Manufacturer Narrative
The production device history record (dhr) for this intra-aortic balloon pump (iabp) was not required to be reviewed per company standard operating procedure since the device manufacture date is greater than one year from the event date. Getinge service was not requested in connection with this event. A fse reported that the iabp associated with this event is a demo pump. The fse was instructed that all demo units will be send back to getinge; therefore the fse has stored the iabp in his garage unit and placed the iabp out of service. A supplemental report will be submitted if additional information is made available.
 
Event Description
It was reported that while a getinge therapy specialist was using the cardiosave intra-aortic balloon pump (iabp) for in-service, the left side of screen of the patient monitor was out. The getinge therapy specialist additionally reported that during demo the iabp while set to auto-mode would not detect ecg signal and would only trigger off of pressure trigger. When the iabp was placed in semi-auto mode, the getinge therapy specialist could trigger off of ecg. Also during demo, the iab catheter was disconnected to show alarm; the iabp continued running without iabp being connected. The iabp was then put in stand-by and the getinge therapy specialist performed iab fill; an autofill failure occurred. In an attempt to solve this issue the getinge therapy specialist disconnected iab and reconnected it, then performed auto-fill and the iabp then function properly. No patient involvement. This iabp only used for demo today.
 
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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
1300 macarthur blvd
mahwah, NJ 07430
MDR Report Key8444900
MDR Text Key139820137
Report Number2249723-2019-00455
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
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/11/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/22/2019
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? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Device Age YR
Event Location No Information
Date Manufacturer Received03/20/2019
Was Device Evaluated by Manufacturer? No
Date Device Manufactured01/01/2012
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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