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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 Premature Discharge of Battery (1057)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/28/2023
Event Type  malfunction  
Event Description
It was reported that during preventive maintenance (pm) performed by a getinge service territory manager (stm) , the cs300 intra-aortic balloon pump (iabp) failed battery run time testing.There was no patient involvement.
 
Manufacturer Narrative
A supplemental report will be submitted upon completion of our investigation.
 
Event Description
N/a.
 
Manufacturer Narrative
The getinge service territory manager(stm) evaluated the unit, and replaced the defective batteries.The stm then completed all required preventive maintenance and functional tests.The unit passed all functional/safety testing.
 
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Brand Name
CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V
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 Key18455941
MDR Text Key332206825
Report Number2249723-2024-00063
Device Sequence Number1
Product Code DSP
UDI-Device Identifier10607567107882
UDI-Public10607567107882
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K063525
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 01/22/2024
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 Number0998-00-3023-53
Device Catalogue Number0998-00-3023-53
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 12/28/2023
Initial Date FDA Received01/05/2024
Supplement Dates Manufacturer Received01/22/2024
Supplement Dates FDA Received01/23/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/24/2010
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
Treatment
N/A.
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