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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 Display or Visual Feedback Problem (1184); Failure to Calibrate (2440)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/23/2018
Event Type  malfunction  
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. A getinge field service engineer (fse) was dispatched to the customer's site. The fse performed fiber optic test upon arrival, and the iabp passed the initial fiber optic test. The fse cleaned the fiber optic assembly, and re-tested the iabp; no significant difference in test results. After physical inspection of the iabp, the fse found the customer's pressure cable tight and not completely seated into the pressure port. The fse suspect the customer's issue was due to a not fully seated pressure cable. The fse then performed all functional and safety checks to meet factory specifications. Unit passed all functional and safety test per factory specifications. The iabp was then released to the customer and cleared for clinical service.
 
Event Description
It was reported that while attempting to set-up a patient with a fiber optic sensation 7fr 40cc to the cs300 intra-aortic balloon pump (iabp), the iabp generated a message stating unable to calibrate. The customer tried with two different iabps and they received the same error message. They brought another iabp from cardiac catheterization lab (ccl) and there was able to get it to calibrate. The first two pumps were sent to the bio-med and awaiting for evaluation. This report is for the second iabp used. No patient injury or adverse event was 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 Key7879679
MDR Text Key120526147
Report Number2249723-2018-01604
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
Report Date 09/14/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/15/2018
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?
Device Age YR
Event Location No Information
Date Manufacturer Received08/23/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/01/2015
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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