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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 Failure to Sense (1559)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/15/2021
Event Type  malfunction  
Manufacturer Narrative
Testing of actual/suspected device (10) a getinge field service engineer (fse) was dispatched to investigate. The fse evaluated the iabp unit but was unable to reproduce the reported issue. The fse identified several autofill errors in the fault log and significant moisture present in the purge line and purge filter and then successfully performed the water condensation removal process. During functional testing, the fse identified that the solenoid driver board voltages out of range for blood back detector. The fse then installed replacement solenoid driver bd and blood detect tubing. The fse performed functional and safety checks to meet factory specifications. The iabp was then released to the customer and cleared for clinical service. A supplemental report will be submitted upon receipt of additional information or completion of our investigation. Additional mdrs will be submitted for the autofill and solenoid driver board malfunctions.
 
Event Description
It was reported that prior to patient use the cs300 intra-aortic balloon pump (iabp) unit is not recognizing the fiber optic. There was no patient involvement and no adverse event was reported.
 
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Brand NameCS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ
MDR Report Key12609324
MDR Text Key281277445
Report Number2249723-2021-02324
Device Sequence Number1
Product Code DSP
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,health
Type of Report Initial
Report Date 10/08/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/11/2021
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
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/15/2021
Is This a Reprocessed and Reused Single-Use Device?

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