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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CS300 INTRA-AORTIC BALLOON PUMP, ITALIAN, 220V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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DATASCOPE CORP. - MAHWAH CS300 INTRA-AORTIC BALLOON PUMP, ITALIAN, 220V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number 0998-00-3023-67
Device Problem No Display/Image (1183)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/15/2024
Event Type  malfunction  
Event Description
It was reported that before use, the cs300 intra-aortic balloon pump (iabp) monitor image was occasionally goes out of sync.There was no patient involvement.
 
Manufacturer Narrative
A supplemental report will be submitted upon completion of our investigation.
 
Manufacturer Narrative
A getinge field service engineer(fse) evaluated unit.Disassembly and cleaning of display contacts.Cleaned coiled cord connector contacts.Repair completed.Operational tests carried out with positive results.The equipment was returned to the customer for clinical use.
 
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Brand Name
CS300 INTRA-AORTIC BALLOON PUMP, ITALIAN, 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 Key18979260
MDR Text Key338610142
Report Number2249723-2024-01259
Device Sequence Number1
Product Code DSP
UDI-Device Identifier10607567112619
UDI-Public10607567112619
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
K063525
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 04/17/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/26/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number0998-00-3023-67
Device Catalogue Number0998-00-3023-67
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/17/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/26/2008
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
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