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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE MAHWAH SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE MAHWAH SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number CS300 INTRA-AORTIC BALLOON PUMP
Device Problem Device Displays Incorrect Message (2591)
Patient Problem Death (1802)
Event Date 07/27/2016
Event Type  Death  
Manufacturer Narrative
Two service representatives observed the "blood detected" alarm in the fault logs and also observed excess of condensation. No blood was present in any tubing. They verified calibration of the condensate removal module, the fan operation of crm the validated calibration of blood detector sensor. The service representatives performed both, condensate removal procedures. Significant amount of condensation noted in purge line during removal process. The iabp was tested to factory specification. It functioned normally and was returned to the customer.
 
Event Description
The customer reported that while the iabp was in use on a patient, the iabp generated a ¿blood back¿ alarm. No replacement iabp was used. The care giver elected to interrupt the iab therapy. No replacement pump was installed. The patient expired 5 hours later. It¿s unknown if the patient death is attributed to the reported event.
 
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Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section G)
DATASCOPE MAHWAH
1300 macarthur blvd.
mahwah NJ 07430
Manufacturer Contact
1300 macarthur blvd.
mahwah, NJ 07430
MDR Report Key5835064
MDR Text Key50805090
Report Number2249723-2016-00023
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
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 07/27/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/29/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberCS300 INTRA-AORTIC BALLOON PUMP
Device Catalogue Number0998-00-3023-53
Other Device ID NumberSI184646K0
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Device AgeYR
Event Location No Information
Date Manufacturer Received07/27/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/03/2010
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 07/29/2016 Patient Sequence Number: 1
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