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U.S. Department of Health and Human Services

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

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DATASCOPE MAHWAH CARDIOSAVE HYBRID TYPE B PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number N/A
Device Problems Inability to Auto-Fill (1044); Device Displays Incorrect Message (2591); Application Program Freezes, Becomes Nonfunctional (4031)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/08/2019
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 the company standard operating procedure since the device manufacture date is greater than one year from the event date. A getinge field service engineer (fse) was dispatched to evaluate this unit and was unable to reproduce the reported issue. The fse reported that the device iabp fill was responsive and able to execute multiple times. The touch screen calibration and display test was completed and passed successfully. The gas loss alarm was unable to be verified but the event logs shows fill fail/shuttle purge time out multiple times. The fse also re-check gas leaks on both external and internal tanks and both passing within specification. The fse was unable to verify if the helium tank was open or close at the time when customer experienced the problem, but it may be caused of the problem including loose or kinked catheter. Full calibration was re-done again despite that the unit is all within specs. The fse then performed full functionality, performance and safety testing. The iabp was returned to the customer and cleared for clinical use.
 
Event Description
It was reported that while placing a patient on bypass, the cardiosave intra-aortic balloon pump (iabp) was placed on standby to cannulate. After 30 seconds of standby, the customer went back to the iabp unit, and it emitted a ¿gas loss¿ alarm. The iabp would not allow the intra-aortic balloon (iab) to be auto-filled, and the iabp button on the touchscreen was not reacting to 2-5 seconds hold of the button. The iabp was switched out to continue patient therapy, and there was no patient harm or adverse event reported. Subsequently, a getinge representative was able to reproduce the reported issue with the screen but 1 out of 3 times the iab fill worked. The getinge representative tested the touchscreen and the iab fill would work 1 out of 3 times it was attempted. The getinge representative also reported that it could be an issue with the end user as ¿gas loss¿ alarm also should not have occurred after 30 seconds of standby time.
 
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Brand NameCARDIOSAVE HYBRID TYPE B PLUG
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE MAHWAH
1300 macarthur blvd.
mahwah NJ 07430
Manufacturer (Section G)
DATASCOPE MAHWAH
1300 macarthur blvd.
mahwah NJ 07430
Manufacturer Contact
1300 macarthur blvd.
mahwah, NJ 07430
MDR Report Key8377855
MDR Text Key138960843
Report Number2249723-2019-00317
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
Type of Report Initial
Report Date 02/27/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/28/2019
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? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/08/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/01/2017
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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