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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 Crack (1135); Device Displays Incorrect Message (2591)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/26/2018
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.(b)(6).Additional information has been requested and will be reporting accordingly upon receipt.
 
Event Description
It was reported that while in use on a patient the cardiosave intra-aortic balloon pump (iabp) generated a fiber optic sensor failure alarm.They were able to obtain pressure via central lumen with a transducer.Upon review, they determined that the issue was the iabp itself and not the catheter.The iabp was cracked and therefore letting light in and disrupting the fiber optic analysis.There was no patient harm and no adverse event was reported.
 
Manufacturer Narrative
The customer has not requested getinge to evaluate the iabp in connection with this event.The customer has advised that no repair information was available; however, no further issues have occurred with the intra-aortic balloon pump.
 
Event Description
It was reported that while in use on a patient the cardiosave intra-aortic balloon pump (iabp) generated a fiber optic sensor failure alarm.They were able to obtain pressure via central lumen with a transducer.Upon review, they determined that the issue was the iabp itself and not the catheter.The iabp was cracked and therefore letting light in and disrupting the fiber optic analysis.There was no patient harm and no 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 Key7358998
MDR Text Key103284767
Report Number2249723-2018-00448
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 Nurse
Type of Report Initial,Followup
Report Date 04/27/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/21/2018
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? No
Is the Reporter a Health Professional? Yes
Device AgeYR
Date Manufacturer Received04/05/2018
Date Device Manufactured12/01/2015
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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