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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 Problem (3005)
Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Event Date 11/19/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(6). Additional information is being requested with regard to the repair and status of the iabp. A supplemental report will be submitted when this information is provided to us.
 
Event Description
It was reported that the cardiosave intra-aortic balloon pump (iabp) has a low vacuum error. 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 Key11015330
MDR Text Key224796302
Report Number2249723-2020-02158
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
K063525
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup,Followup
Report Date 03/18/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/15/2020
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? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/18/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/01/2003
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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