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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE CORP. - MAHWAH CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number 0998-00-3023-53
Device Problem Power Problem (3010)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/07/2021
Event Type  malfunction  
Manufacturer Narrative
A getinge authorized dealer's field service engineer (fse) evaluated the iabp unit and was able to confirm the reported issue.To fix the issue, the fse replaced the power supply and 5000 hours maintenance package.The fse then turned on the iabp and confirmed that the power supply of the iabp was working normally (battery charging and discharging and ac power).Additional information is being requested with regard to the status of the iabp.A supplemental report will be submitted when this information is provided to us.
 
Event Description
It was reported that the cs300 intra-aortic balloon pump (iabp) had power supply issues.It is unknown the circumstances under which the event occurred.It is also unknown if there was patient involvement.However, there was no adverse event reported.
 
Manufacturer Narrative
A getinge service representative reported that the getinge authorized dealer's field service engineer (fse) had performed all functional and safety checks to meet factory specifications.Unit had passed all functional and safety test per factory specifications.The iabp was then released to the customer and cleared for clinical service.
 
Event Description
It was reported that during a routine check the cs300 intra-aortic balloon pump (iabp) had power supply issues.There was no patient involvement, and no adverse event reported.
 
Manufacturer Narrative
Analysis of production: (3331/213) the device history records review concluded that there were no ncmrs, rework, or deviations documented for the reported lot/serial number.Based on the dhr/lhr review results, it was determined that there is no relation between the manufacturing process and the reported failure.Historical data analysis: (4109/213) the review of the historical data indicates that no other similar complaint was reported for the same lot/serial number and reported failure mode.Trend analysis: (4110/213) the overall 12 month product complaint trend data for the period feb 2020 through jan 2021 was reviewed.There were no triggers identified for the review period.
 
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Brand Name
CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ 07430
Manufacturer (Section G)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ 07430
Manufacturer Contact
brian schaeffer
1300 macarthur blvd
mahwah, NJ 07430
MDR Report Key11297065
MDR Text Key230988548
Report Number2249723-2021-00227
Device Sequence Number1
Product Code DSP
UDI-Device Identifier10607567107882
UDI-Public10607567107882
Combination Product (y/n)N
Reporter Country CodeTW
PMA/PMN Number
K063525
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup,Followup
Report Date 04/21/2022
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 Number0998-00-3023-53
Device Catalogue Number0998-00-3023-53
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 01/15/2021
Initial Date FDA Received02/08/2021
Supplement Dates Manufacturer Received10/27/2021
04/21/2022
Supplement Dates FDA Received11/16/2021
05/16/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/22/2012
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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