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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 220V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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DATASCOPE CORP. 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 Electrical /Electronic Property Problem (1198); Appropriate Term/Code Not Available (3191)
Patient Problems Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 02/01/2022
Event Type  malfunction  
Event Description
It was reported that the customer has decided to purchase a new iabp as opposed to repairing the cs300 intra-aortic balloon pump.It is unknown what required repair or what the malfunction was.It is also unknown under which circumstances the event occurred or if a patient was involved; however there was no adverse event reported.
 
Manufacturer Narrative
Type of investigation not yet determined: (4118/3233): a supplemental report will be submitted upon receipt of additional information.
 
Manufacturer Narrative
Device not accessible for testing (4117): a getinge field service engineer (fse) spoke to the customer who indicated that a new iabp will be purchased.The cs300 reported will not be repaired.A supplemental report will be submitted upon completion of our evaluation.H3 other text : not returned to manufacturer.
 
Event Description
It was reported that the transducer calibration on the cs300 intra-aortic balloon pump (iabp) failed.It is unknown under which circumstances the event occurred or if a patient was involved; however there was no adverse event reported.
 
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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.
14 philips parkway
montvale NJ
Manufacturer (Section G)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ
Manufacturer Contact
arelean guzman
1300 macarthur blvd
mahwah, NJ 
MDR Report Key13638864
MDR Text Key290000790
Report Number2249723-2022-00417
Device Sequence Number1
Product Code DSP
UDI-Device Identifier10607567112541
UDI-Public10607567112541
Combination Product (y/n)N
Reporter Country CodeAS
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 03/07/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/01/2022
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
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Date Manufacturer Received03/02/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/26/2009
Type of Device Usage Reuse
Patient Sequence Number1
Treatment
UNKNOWN.
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