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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 01/18/2018
Event Type  malfunction  
Manufacturer Narrative
The customer reported that it is unknown when the iabp will be repaired or released for clinical use.
 
Event Description
It was reported that during the solenoid driver board field action by a getinge field service engineer (fse), the cs300 intra-aortic balloon pump (iabp) failed the battery run time test. The iabp ran on the back up battery for 255 minutes after a full charge. 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. The field service engineer (fse) completed the field action and safety checks to factory specifications. In addition the fse advised the customer not to return the iabp to clinical service until an investigation was performed. The customer agreed, but did not want any action taken at this time. (b)(6). A supplemental report will be submitted if additional information is provided.
 
Event Description
It was reported that during the solenoid driver board field action by a getinge field service engineer (fse), the cs300 intra-aortic balloon pump (iabp) failed the battery run time test. The iabp ran on the back up battery for 255 minutes after a full charge. 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 Key7259898
MDR Text Key110616465
Report Number2249723-2018-00221
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,user f
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/05/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/09/2018
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? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/11/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured05/01/2001
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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