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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE MAHWAH CARDIOSAVE; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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DATASCOPE MAHWAH CARDIOSAVE; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number N/A
Device Problems No Display/Image (1183); Loss of Power (1475); Device Displays Incorrect Message (2591)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/05/2017
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.
 
Event Description
It was reported that while the cardiosave intra-aortic balloon pump (iabp) was used on a patient and upon transferring of the patient, the iabp stopped pumping and the monitor went black, then the iabp alarmed and shutdown.An attempt was made to power on the iabp by turning it off and on.The iabp then restarted pumping normally.No patient harm or adverse event was reported.
 
Manufacturer Narrative
The getinge field service engineer (fse) evaluated the iabp and was unable to duplicate the reported malfunction.However, as a precaution the fse replaced the cable, to backplane cable cord and the coiled cable.The fse the performed all functional and safety checks to meet factory specifications.The iabp passed all functional and safety test per factory specifications.The iabp was then released to the customer and cleared for clinical service.
 
Event Description
It was reported that while the cardiosave intra-aortic balloon pump (iabp) was used on a patient and upon transferring of the patient, the iabp stopped pumping and the monitor went black, then the iabp alarmed and shutdown.An attempt was made to power on the iabp by turning it off and on.The iabp then restarted pumping normally.No patient harm or adverse event was reported.
 
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Brand Name
CARDIOSAVE
Type of Device
SYSTEM, 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 Key7148381
MDR Text Key96172341
Report Number2249723-2017-01067
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K112372
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 02/12/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/27/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number0998-00-0800-XX
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Device AgeYR
Date Manufacturer Received12/08/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/01/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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