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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CS300 SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE CORP. - MAHWAH CS300 SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number N/A
Device Problems Inability to Auto-Fill (1044); Leak/Splash (1354)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/02/2020
Event Type  malfunction  
Manufacturer Narrative
The full event site name is (b)(6). The getinge field service engineer (fse) that encountered the issue was unable to reproduce the reported issue during service. However, upon reviewing the cs300 intra-aortic balloon pump (iabp) unit logs, the fse verified that the unit had a autofill failure and leak in the iab circuit messages. The fse determined that the issue was likely caused by the balloon, or balloon connections. To fix the issue, the fse replaced the safety disk and the unit was allowed to operate for an extended period of time without any issue. The fse performed all functional and safety checks to meet factory specifications. The iabp was then released to the customer for return to clinical service.
 
Event Description
It was reported that the customer requested repair service for the cs300 intra-aortic balloon pump (iabp) unit in relation to an unspecified issue. After a getinge field service engineer (fse) evaluated the unit, it was further reported that the iabp unit had an autofill failure & leak in iab circuit messages. It is unknown the circumstances under which the event occurred. It is also unknown if there was a patient involvement. However, there was no adverse event reported.
 
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Brand NameCS300
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
dorota wolpiuk
1300 macarthur blvd
mahwah, NJ 07430
MDR Report Key10898312
MDR Text Key218983387
Report Number2249723-2020-02009
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K063525
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/29/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/24/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number0998-00-3023-53
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/08/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/01/2013
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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