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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CS100 INTRA-AORTIC BALLOON PUMP, REFURBISHED, ENGLISH,NON-UTS,DOM; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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DATASCOPE CORP. - MAHWAH CS100 INTRA-AORTIC BALLOON PUMP, REFURBISHED, ENGLISH,NON-UTS,DOM; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number 0998-00-3013-55
Device Problem Gas Output Problem (1266)
Patient Problems Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 04/07/2022
Event Type  malfunction  
Event Description
It was reported that the cs100 intra-aortic balloon pump (iabp) had a helium problem due to an empty helium tank.It is unknown under which circumstances the event occurred or if a patient was involved; however there was no adverse event reported.
 
Manufacturer Narrative
A supplemental report will be submitted upon receipt of additional information.
 
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Brand Name
CS100 INTRA-AORTIC BALLOON PUMP, REFURBISHED, ENGLISH,NON-UTS,DOM
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 Key14523505
MDR Text Key292825165
Report Number2249723-2022-01258
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeHK
PMA/PMN Number
K031636
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 02/26/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/27/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number0998-00-3013-55
Device Catalogue Number0998-00-3013-55
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received02/24/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/02/2011
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
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