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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 Problem Mechanical Problem (1384)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/15/2018
Event Type  malfunction  
Manufacturer Narrative
The production device history record (dhr) for this iabp unit is not required to be reviewed per getinge standard operating procedure since the iabp was manufactured more than a year before the date of event. The getinge stm that found the issue replaced the fiber optic module assembly and the problem was resolve. The stm then performed all functional and safety test as per factory specifications. The iabp was then returned to the customer and cleared for clinical use. The initial reporter named is a getinge employee who has different contact details from that of the event site, and has the following contact information: (b)(4).
 
Event Description
It was reported that the cs300 intra-aortic balloon pump (iabp) failed the fiber optic module test during a preventative maintenance performed by a getinge service territory manager (stm). There was no patient involvement and no 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 Key8046528
MDR Text Key128261892
Report Number2249723-2018-01930
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
Report Date 11/07/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/07/2018
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?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/15/2018
Was Device Evaluated by Manufacturer? Yes
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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