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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
Catalog Number 0998-00-3023-53
Device Problem Incorrect Or Inadequate Test Results (2456)
Patient Problem No Patient Involvement (2645)
Event Date 05/15/2018
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 field service engineer (fse) replaced the batteries which did not meet the specification time limit. He then performed functional and safety checks to meet factory specifications. The unit was then released back to the customer. The initial reporter is a getinge employee who has different contact details from that of the event site, and has the following contact information: (b)(6).
 
Event Description
A getinge field service engineer (fse) reported that during an service test the cs300 intra-aortic balloon pump (iabp) failed battery run time test. There was no patient involvement, therefore 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 Key7569657
MDR Text Key110345080
Report Number2249723-2018-00945
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 06/04/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/05/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number0998-00-3023-53
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 Received05/15/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/01/2008
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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