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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 Failure of Device to Self-Test (2937)
Patient Problem No Patient Involvement (2645)
Event Date 06/27/2018
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 the company standard operating procedure since the device manufacture date is greater than one year from the event date.Battery replacement and preventive maintenance (pm) will be performed by the customer.If additional information is provided by the customer, we will submit a supplemental report.The initial reporter is a getinge designee whose contact details are different from that of the event site.Please refer to the following email and phone number as contact information for the initial reporter (b)(6).
 
Event Description
It was reported that while a getinge designee was performing field action update on the cs300 intra-aortic balloon pump (iabp), the batteries failed the fun time test.There was no patient involvement, and no adverse event was reported.
 
Manufacturer Narrative
The customer has advised that the batteries were replaced on (b)(6)2018, and the iabp was cleared for clinical service.
 
Event Description
It was reported that while a getinge designee was performing field action update on the cs300 intra-aortic balloon pump (iabp), the batteries failed the fun time test.There was no patient involvement, and no adverse event was reported.
 
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Brand Name
CS300
Type of Device
SYSTEM, 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 Key7722911
MDR Text Key115277763
Report Number2249723-2018-01259
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 Other
Type of Report Initial,Followup
Report Date 11/01/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
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? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 07/06/2018
Initial Date FDA Received07/26/2018
Supplement Dates Manufacturer Received10/09/2018
Supplement Dates FDA Received11/02/2018
Was Device Evaluated by Manufacturer? No
Date Device Manufactured12/01/2006
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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