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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 Break (1069); Device Damaged Prior to Use (2284)
Patient Problem No Patient Involvement (2645)
Event Date 12/04/2020
Event Type  malfunction  
Manufacturer Narrative
The full name of the initial reporter in is (b)(6). The initial reporter named in is a getinge employee who has different contact details from that of the event site. Please refer to the following email and phone number: (b)(6). A getinge engineer evaluated the iabp and discovered that the cs300 monitor was damaged. Initial inspection suggested trauma; further inspection revealed a unknown solution ingressed. The fse replaced the lcd, display mount, and display cable, and the display began functioning properly and no issue could be reproduced. The pm was completed with full calibration, functional and safety checks to meet factory specifications. Unit passed all calibration, functional and safety test per factory specifications. This iabp is used by the r&d department at getinge fairfield for testing purposes only. It is not used for clinical purposes and is never used on patients.
 
Event Description
It was reported that during preventive maintenance (pm) performed by a getinge field service engineer (fse), the cs300 intra-aortic balloon pump (iabp) had a damaged monitor. There was no patient involvement, and 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 Key11065934
MDR Text Key223448468
Report Number2249723-2020-02183
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
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 01/19/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/23/2020
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? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/19/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/01/2009
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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