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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CS300; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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DATASCOPE CORP. - MAHWAH CS300; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number N/A
Device Problem Power Problem (3010)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/23/2020
Event Type  malfunction  
Manufacturer Narrative
A getinge field service engineer (fse) was dispatched to investigate.The fse evaluated the iabp unit and was able to reproduce the reported issue.Specifically, the fse observed an abnormality in the power supply, and therefore, determined that the reported issue was caused by the defective power supply assembly.The fse ordered a replacement power supply assembly, and upon receipt, repairs can continue.Additional information is being requested with regard to the repair and status of the iabp unit.A supplemental report will be submitted when this information is provided to us.
 
Event Description
It was reported that during use on a patient, the cs300 intra-aortic balloon pump (iabp) unit system would only operate on battery-power, despite the fact that the power cord was plugged into the ac outlet.It was also reported that the unit was switched with another unit to perform patient therapy.No patient harm, serious injury or adverse event was reported.
 
Manufacturer Narrative
A getinge field service engineer (fse) evaluated the iabp unit and was able to reproduce the reported issue.Specifically, the fse observed an abnormality in the power supply, and therefore, determined that the reported issue was caused by the defective power supply assembly.To fix the issue, the fse replaced the power supply assembly, and then performed all functional and safety checks to meet factory specifications.The iabp was then released to the customer for return to clinical service.
 
Event Description
It was reported that during use on a patient, the cs300 intra-aortic balloon pump (iabp) unit system would only operate on battery-power, despite the fact that the power cord was plugged into the ac outlet.It was also reported that the unit was switched with another unit to perform patient therapy.No patient harm, serious injury or adverse event was reported.
 
Event Description
It was reported that during use on a patient, the cs300 intra-aortic balloon pump (iabp) unit system would only operate on battery-power, despite the fact that the power cord was plugged into the ac outlet.It was also reported that the unit was switched with another unit to perform patient therapy.No patient harm, serious injury or adverse event was reported.
 
Manufacturer Narrative
At the customer's request, the faulty power supply was sent to getinge's national repair center (nrc) for failure investigation.A getinge senior repair technician inspected the power supply and no visual damage was observed.The power supply was installed in the cs300 test fixture and was tested to factory specifications.The power supply failed testing and the reported issue was verified with the iabp unit running on battery power but not with ac power applied.It was observed that the 10 amp ac input fuse was blown.The power supply was sent to the supplier for failure investigation.The supplier verified the failure and stated that the main bulk fets (q1, q2) was shorted and main ac input fuses are open (f1, f2).It was reported that the power supply would be scrapped by the supplier since the part is obsolete.
 
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Brand Name
CS300
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ 07430
MDR Report Key11181098
MDR Text Key227747149
Report Number2249723-2021-00086
Device Sequence Number1
Product Code DSP
UDI-Device Identifier10607567108322
UDI-Public10607567108322
Combination Product (y/n)N
PMA/PMN Number
K063525
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 04/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/15/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number0998-00-3023-65
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/31/2021
Date Manufacturer Received03/31/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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