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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 Problem Output below Specifications (3004)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/17/2020
Event Type  malfunction  
Manufacturer Narrative
The production device history record (dhr) for this intra-aortic balloon pump (iabp) was not required to be reviewed as per company standard operating procedure since the device manufacture date is greater than one year from the event date. The full name of the event site was shortened due to field character limit; the full name is (b)(4). A getinge service territory manager (stm) was dispatched to evaluate the iabp unit. The stm was unable to duplicate the low vacuum alarm but verified the low vacuum alarm and autofill failure in the event log. The issue was isolated to the drive manifold. The drive manifold was replaced. The stm noted a worn iab fill port fitting and replaced that as a preventative measure. The 2500 maintenance kit was installed in accordance with manufacturer's recommendation. The stm completed all safety, functionality, and calibration checks and all tests passed to factory specifications. The iabp unit was cleared for clinical use and released to the customer.
 
Event Description
It was reported that a low vacuum alarm occurred on a cs300 intra-aortic balloon pump (iabp). It is unknown under which circumstances this occurred; however there was no known harm or injury to patient and no adverse event was 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
1300 macarthur blvd
mahwah, NJ 07430
MDR Report Key9818605
MDR Text Key190799807
Report Number2249723-2020-00392
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
Report Date 03/09/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/11/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
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?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/17/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/01/2015
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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