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U.S. Department of Health and Human Services

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

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DATASCOPE MAHWAH CS300 SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number N/A
Device Problems Image Display Error/Artifact (1304); Mechanical Problem (1384)
Patient Problem No Patient Involvement (2645)
Event Date 11/05/2017
Event Type  malfunction  
Manufacturer Narrative
The customer has not requested getinge to evaluate the iabp. However, the customer has advised that the lcd display was replaced and the iabp was returned to clinical service.
 
Event Description
The customer reported that while the cs300 intra-aortic balloon pump (iabp) was in use on a patient, it experienced a mechanical problem causing the screen to continuously flicker. There was no adverse event reported.
 
Manufacturer Narrative
The production device history record (dhr) for this intra-aortic balloon pump (iabp) was not required to be reviewed per company standard operating procedure since the device manufacture date is greater than one year from the event date. At this time, the customer has not requested getinge to evaluate the iabp. Additional information has been requested from the customer with regard to the repair and status of the iabp, and a supplemental report will be sent if this information is provided to us.
 
Event Description
The customer reported that while the cs300 intra-aortic balloon pump (iabp) was in use on a patient, it experienced a mechanical problem causing the screen to continuously flicker. There was no adverse event reported.
 
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Brand NameCS300
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE MAHWAH
1300 macarthur blvd.
mahwah NJ 07430
Manufacturer (Section G)
DATASCOPE MAHWAH
1300 macarthur blvd.
mahwah NJ 07430
Manufacturer Contact
1300 macarthur blvd.
mahwah, NJ 07430
MDR Report Key7061648
MDR Text Key104058091
Report Number2249723-2017-00868
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
Report Date 03/27/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/27/2017
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? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Device AgeYR
Event Location No Information
Date Manufacturer Received03/21/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured02/01/2009
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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