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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE MAHWAH CS100; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE MAHWAH CS100; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number N/A
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/04/2018
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 cs100 unit is an end of life product and is not supported by getinge.If additional information is provided by the customer, we will submit a supplemental report.(b)(6).
 
Event Description
It was reported that while a uhs representative was performing field action repair on the cs100 intra-aortic balloon pump (iabp), the battery run time test failed.There was no patient involvement, and no adverse event was reported.
 
Manufacturer Narrative
The customer has advised that the iabp has since passed a preventative maintenance checkout, no problems were noted and the iabp is in clinical use.
 
Event Description
It was reported that while a uhs representative was performing field action repair on the cs100 intra-aortic balloon pump (iabp), the battery run time test failed.There was no patient involvement, and no adverse event was reported.
 
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Brand Name
CS100
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 Key7639168
MDR Text Key112559254
Report Number2249723-2018-01084
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K031636
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 09/03/2018
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 Model NumberN/A
Device Catalogue Number0998-00-3013-53
Device Lot NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 06/04/2018
Initial Date FDA Received06/26/2018
Supplement Dates Manufacturer Received08/14/2018
Supplement Dates FDA Received09/06/2018
Date Device Manufactured08/01/2003
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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