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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 04/16/2018
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. The uhs technician performed the field actions on this unit, but was unable to perform battery run time test due to the battery not being fully charged. The customer is servicing the iabp themselves, and will not require getinge to perform any work. The iabp was returned to the customer, but not cleared for clinical use. A preventative maintenance (pm) and battery run time test are required prior to release for clinical use. A supplemental report will be submitted if subsequent information is provided.
 
Event Description
It was reported that the cs300 intra-aortic balloon pump (iabp) failed the battery run test during a field action update. There was no patient involvement and no adverse event was reported.
 
Event Description
It was reported that while a getinge designee was performing a field action update on the cs300 intra-aortic balloon pump (iabp), the designee was unable to perform the battery run time due to the batteries not being fully charged. 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 Key7544284
MDR Text Key109497417
Report Number2249723-2018-00889
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,distri
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/30/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/25/2018
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 Received08/20/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured01/01/2007
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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