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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 Inflation Problem (1310)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/15/2024
Event Type  malfunction  
Manufacturer Narrative
A supplemental report will be submitted upon completion of our investigation.
 
Event Description
It was reported that during use on a patient, the cs100 intra-aortic balloon pump (iabp) after the patient had cardiac arrest and was put on ecmo, the aortic valve had difficulty opening and needed to be combined with iabp for assisted circulation.After the intra-aortic balloon was inserted and connected to the intra-aortic balloon pump, the machine alarmed "inflation failure" and could not be used normally.The unit was shutdown and there were no personnel were injured.
 
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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 Key19203755
MDR Text Key341398944
Report Number2249723-2024-01725
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
Report Date 04/29/2024
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
Initial Date Manufacturer Received 04/16/2024
Initial Date FDA Received04/29/2024
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
Treatment
UNKNOWN.
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