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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, 220V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE CORP. - MAHWAH CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 220V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number 0998-00-3023-55
Device Problems Component Incompatible (1108); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/07/2022
Event Type  malfunction  
Manufacturer Narrative
A supplemental report will be submitted upon completion of our investigation.
 
Event Description
It was reported that during use on a patient, the cs300 intra-aortic balloon pump (iabp) one of the valves allows vacuum.
 
Event Description
It was reported that during preventive maintenance (pm) performed by a getinge field service engineer (fse) the cs300 intra-aortic balloon pump (iabp) drive manifold had a valve allowing vacuum.There was no patient involvement.
 
Manufacturer Narrative
The fse that encountered the issue stated that one of the valves of the drive manifold was leaking.The fse detected the defect during functional tests of a preventive inspection.The fse replaced the drive manifold (0104-00-0018).An adjustment and functional check were carried out according to the manufacturer's recommendations.A btk of the unit's counter-pulsation device was also carried out.The iabp was returned to the customer and cleared for clinical use.
 
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Brand Name
CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 220V
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ
Manufacturer (Section G)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ
Manufacturer Contact
arelean guzman
1300 macarthur blvd
mahwah, NJ 
MDR Report Key16028730
MDR Text Key308369091
Report Number2249723-2022-03254
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeEZ
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 Non-Healthcare Professional
Type of Report Initial,Followup,Followup
Report Date 05/04/2023
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 Number0998-00-3023-55
Device Catalogue Number0998-00-3023-55
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 12/07/2022
Initial Date FDA Received12/21/2022
Supplement Dates Manufacturer Received05/03/2023
05/04/2023
Supplement Dates FDA Received05/04/2023
05/05/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/14/2011
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
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