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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE MAHWAH CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE MAHWAH CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0998-00-0800-53
Device Problem Device Inoperable (1663)
Patient Problem No Code Available (3191)
Event Date 09/12/2016
Event Type  Injury  
Manufacturer Narrative
The device history record (dhr) for the iabp involved in the event was reviewed. There were no non conformances noted in dhr related to the reported event. The company representative was unable to duplicate the reported problem however he observed on the fault logs fault code#53 (dc proxy overrun detected software performance error). He reloaded the system software. The iabp was tested to factory specification. It functioned normally and was returned to the customer.
 
Event Description
Customer reported: during coronary artery bypass graft x3 with left internal mammary artery an intra-aortic balloon pump (iabp) was used. Further, via fda mw report 5065066 received with the company on october 11, 2016 with regards to the same event; the customer reported the balloon pump stopped working and the patient's blood pressure went down. The patient was switched to another iabp and therapy was completed with no reports of any adverse event to the patient.
 
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Brand NameCARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP)
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 Key6080792
MDR Text Key59220988
Report Number2249723-2016-00034
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 10/11/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/04/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number0998-00-0800-53
Other Device ID NumberCA241760B4
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 Received10/11/2016
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured02/01/2014
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: 11/04/2016 Patient Sequence Number: 1
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