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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID W/ E/F PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID W/ E/F PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number 0998-00-0800-55
Device Problems Leak/Splash (1354); Gas/Air Leak (2946); Insufficient Information (3190)
Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/20/2023
Event Type  malfunction  
Manufacturer Narrative
A supplemental report will be submitted upon completion of our investigation.
 
Event Description
It was reported that, the cardiosave intra-aortic balloon pump (iabp) unit has inhouse repairs.
 
Event Description
It was reported that, the cardiosave intra-aortic balloon pump (iabp) unit has inhouse repairs for helium leak.
 
Manufacturer Narrative
Corrected data: b5, h6 (problem code).Updated data: b4, e1(initial reporter), e2, e3, g2, g3, g6, h2, h10, h11.
 
Event Description
It was reported that before use, the cardiosave intra-aortic balloon pump (iabp) unit has inhouse repairs for helium leak.There was no patient involved.
 
Manufacturer Narrative
It was reported that the cardiosave intra-aortic balloon pump (iabp) helium leak.Getinge field service engineer (fse) the problem was confirmed directly in the laboratory.Work performed: disassembly of the crankcase, replacement of the complete fill manifold.Functional checks and diagnostic tests.Preventive replacement of the o-ring connection between the trolley and the console carried out.Regular functioning tests.Final result: repair completed.The device has passed all performance and safety tests according to the parent company's specifications.No patient involved.
 
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Brand Name
CARDIOSAVE HYBRID W/ E/F PLUG
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 Key18435690
MDR Text Key331792296
Report Number2249723-2024-00025
Device Sequence Number1
Product Code DSP
UDI-Device Identifier10607567108414
UDI-Public10607567108414
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
K112372
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,Followup
Report Date 03/29/2024
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 Number0998-00-0800-55
Device Catalogue Number0998-00-0800-55
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/20/2023
Initial Date FDA Received01/03/2024
Supplement Dates Manufacturer Received02/06/2024
02/23/2024
03/26/2024
Supplement Dates FDA Received02/07/2024
02/27/2024
03/31/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/04/2022
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
Treatment
N/A.; UNKNOWN.
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