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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 Display or Visual Feedback Problem (1184)
Patient Problems Shock (2072); No Patient Involvement (2645)
Event Date 03/15/2020
Event Type  malfunction  
Manufacturer Narrative
The production device history record (dhr) for this iabp unit was reviewed and no non-conformances related to the reported event were noted. A getinge service territory manager (stm) was dispatched to the customer's site. The stm evaluated the iabp and was able to reproduce the display issue. The stm replaced the main board that corrected this problem. The stm then performed all calibration, functional and safety tests on iabp, which passed. The iabp was returned to customer and cleared for clinical use. We have requested the main board to be returned to factory for evaluation. A supplemental report will be submitted upon evaluation.
 
Event Description
It was reported before use by the customer, that cs300 intra-aortic balloon pump (iabp) had no display after attempting to connect to the hospital his. The end user reported getting a shock but was not hurt. There was no patient involvement. There was no adverse event was reported to patient and end user due to shock. In relation to the shock of t the end user, it was later also reported that the customer had not started using the iabp as yet. They plugged it in and was getting it ready for use, and the nurse plugged the connection for the hospital into the wrong port of the balloon pump (phone) then the unit shut down so they replaced it with another pump before beginning therapy. * no display after attempting to connect h g1152pumcst0000.
 
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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 Key9947874
MDR Text Key187303438
Report Number2249723-2020-00600
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,health
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 09/01/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/10/2020
Is this an Adverse Event Report? Yes
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 Received08/17/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/24/2015
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: 04/10/2020 Patient Sequence Number: 1
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