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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CS100 INTRA-AORTIC BALLOON PUMP, CHINESE, 220V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE CORP. - MAHWAH CS100 INTRA-AORTIC BALLOON PUMP, CHINESE, 220V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number 0998-00-3013-45
Device Problem Pressure Problem (3012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/18/2024
Event Type  malfunction  
Event Description
It was reported that during inspection by the hospital engineer, the cs100 intra-aortic balloon pump (iabp) negative pressure of the equipment was insufficient.It was not found during use and there was no patient harm reported.
 
Manufacturer Narrative
A supplemental report will be submitted upon completion of our investigation.
 
Manufacturer Narrative
A getinge field service engineer (fse) evaluated the unit and found that the maintenance kit was not replaced regularly, and the 5000-hour maintenance kit needed to be replaced.The customer refused the repair after the quotation was provided, and the customer reported that the maintenance had been carried out through a third party.The customer was informed that unqualified repairs are risky and are not recommended for clinical use.
 
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Brand Name
CS100 INTRA-AORTIC BALLOON PUMP, CHINESE, 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 Key18608749
MDR Text Key334513410
Report Number2249723-2024-00374
Device Sequence Number1
Product Code DSP
UDI-Device Identifier10607567107790
UDI-Public10607567107790
Combination Product (y/n)N
Reporter Country CodeCH
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
Type of Report Initial,Followup
Report Date 03/26/2024
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 Number0998-00-3013-45
Device Catalogue Number0998-00-3013-45
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 01/18/2024
Initial Date FDA Received01/30/2024
Supplement Dates Manufacturer Received03/26/2024
Supplement Dates FDA Received03/26/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/06/2012
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
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