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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 Incorrect Or Inadequate Test Results (2456)
Patient Problem No Patient Involvement (2645)
Event Date 12/20/2017
Event Type  malfunction  
Manufacturer Narrative
The field service engineer (fse) returned and performed the "software retrofit field corrective action". As per instruction the fse installed new datasets. The intra-aortic balloon pump (iabp) passed all calibration, functional, and safety tests performed. The iabp was then returned to the customer and cleared for clinical use.
 
Event Description
It was reported that during service test performed by a company representative on the cs300 intra-aortic balloon pump (iabp) the field service engineer (fse) made an attempt to complete software field service action and after installing the software he performed service diagnostics and the autofill test failed. There was no patient involvement or 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. A getinge field service engineer (fse) attempted to complete software field service action, and after installing software he performed a service diagnostics and the auto-fill test failed. The fse tried another set of datasets, but the problem persisted. He then installed old b03i b03d and the problem was resolved. The fse reassembled the iabp to its initial state. Fse will return at later date to complete software fsa. Then performed functional and safety checks to meet factory specifications. The iabp was released to the customer and cleared for clinical service. The initial reporter named in report is a getinge employee who has different contact details from that of the event site. Details: (b)(6).
 
Event Description
It was reported that during service test performed by a company representative on the cs300 intra-aortic balloon pump (iabp) the field service engineer (fse) made an attempt to complete software field service action and after installing the software he performed service diagnostics and the autofill test failed. There was no patient involvement or 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 Key7187348
MDR Text Key108227063
Report Number2249723-2018-00058
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,Followup
Report Date 04/27/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/12/2018
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? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/29/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/01/2008
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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