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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. CS100 INTRA-AORTIC BALLOON PUMP, REFURBISHED, ENGLISH,NON-UTS,INTL; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE CORP. CS100 INTRA-AORTIC BALLOON PUMP, REFURBISHED, ENGLISH,NON-UTS,INTL; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number 0998-UC-3013-55
Device Problem Premature Discharge of Battery (1057)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/12/2023
Event Type  malfunction  
Manufacturer Narrative
A supplemental report will be submitted upon completion of our investigation.
 
Event Description
It was reported that during general use it was found that the cs100 intra-aortic balloon pump (iabp) battery back up time is low.There was no patient involvement reported.
 
Manufacturer Narrative
A getinge field service engineer (fse) was dispatched to evaluate the unit.The fse reported that there was a low battery backup.The (fse) reported that after replacing the unit's batteries the unit was handed back to customer in good working condition.
 
Event Description
N/a.
 
Manufacturer Narrative
**udi related data quality updates only** providing updated device identification information in alignment with gudid (d1, d2, d3, d4, g4, h4, h5).
 
Event Description
N/a.
 
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Brand Name
CS100 INTRA-AORTIC BALLOON PUMP, REFURBISHED, ENGLISH,NON-UTS,INTL
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP.
1300 macarthur blvd
mahwah NJ 07430
Manufacturer (Section G)
DATASCOPE CORP.
1300 macarthur blvd
mahwah NJ 07430
Manufacturer Contact
arelean guzman
1300 macarthur blvd
mahwah, NJ 07430
MDR Report Key18372655
MDR Text Key331105069
Report Number2249723-2023-05419
Device Sequence Number1
Product Code DSP
UDI-Device Identifier10607567107875
UDI-Public(01)10607567107875(21)SA05391-E6
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
K031636
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 09/21/2024
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 Health Professional
Device Model Number0998-UC-3013-55
Device Catalogue Number0998-UC-3013-55
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/12/2023
Initial Date FDA Received12/21/2023
Supplement Dates Manufacturer Received03/29/2024
09/21/2024
Supplement Dates FDA Received04/01/2024
09/30/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/29/2013
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
Treatment
N/A.
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