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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 Audible Alarm (1019); Backflow (1064); Device Contamination with Body Fluid (2317)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 04/05/2019
Event Type  malfunction  
Manufacturer Narrative
The production device history record (dhr) for this intra-aortic balloon pump (iabp) was not required to be reviewed as per company standard operating procedure since the device manufacture date is greater than one year from the event date. Getinge service has not been requested in connection with this event. However, the facility's biomedical department personnel has advised that on the day of the event, the unit was scheduled for a preventative maintenance (pm). Subsequently, they were able to perform the pm after the iabp support was discontinued on this patient. The biomed that performed the pm has provided us with the fault logs and indicate that the logs did not show anything of note. It appears that the unit has been returned to clinical use after the pm, but we have requested confirmation of this. A supplemental report will be submitted if we receive this additional information.
 
Event Description
It was reported that during use on a patient, the cardiosave intra-aortic balloon pump (iabp) experienced a blood back event. It was noted by the intensive care unit (icu) nurse that there was blood in the helium extender tubing but the iabp unit did not alarm or go into standby. The physician requested to know why the unit did not alarm at the time of the event. There was no patient harm and 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
1300 macarthur blvd
mahwah, NJ 07430
MDR Report Key8580720
MDR Text Key144162566
Report Number2249723-2019-00737
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 Other Health Care Professional
Type of Report Initial,Followup
Report Date 06/04/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/04/2019
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? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Device Age YR
Event Location No Information
Date Manufacturer Received05/09/2019
Was Device Evaluated by Manufacturer? No
Date Device Manufactured03/01/2016
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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