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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 Filling Problem (1233)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/05/2017
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.
 
Event Description
The customer reported that the cs300 intra-aortic balloon pump (iabp) while in use on a patient an auto fill issue occurred.There was no patient injury, death or adverse event reported.
 
Manufacturer Narrative
09/22/2017 02:25 pm (gmt-4:00) added by (b)(6) (pid-(b)(4)): the getinge field service engineer (fse) evaluated the intra-aortic balloon pump (iabp) and received an (etf) electrical test fails code # 53 indicating that the shuttle transducer value was out of range.So the fse replaced the shuttle transducer.The iabp successfully passed all calibration, functional and safety tests according to factory specifications.The iabp was returned to the customer and cleared for clinical use.
 
Event Description
The customer reported that the cs300 intra-aortic balloon pump (iabp) while in use on a patient an auto fill issue occurred.There was no patient injury, death or adverse event 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 Key6830468
MDR Text Key84127997
Report Number2249723-2017-00376
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,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 09/22/2017
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 Health Professional
Device Catalogue Number0998-00-3023-53
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Device AgeYR
Initial Date Manufacturer Received 08/07/2017
Initial Date FDA Received08/30/2017
Supplement Dates Manufacturer Received08/18/2017
Supplement Dates FDA Received09/24/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/01/2010
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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