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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID, TYPE B PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID, TYPE B PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number 0998-00-0800-53
Device Problem Gas/Air Leak (2946)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/13/2024
Event Type  malfunction  
Event Description
It was reported that before use the cardiosave intra-aortic balloon pump (iabp) was leaking helium where tank was draining.There was no patient involvement.
 
Manufacturer Narrative
A supplemental report will be submitted upon completion of our investigation.
 
Manufacturer Narrative
A getinge field service engineer (fse) was dispatched to evaluate the unit.The (fse) reported that they were unable to reproduce the issue.The fse retightened loose high pressure helium connections, and verified there was no leak in cart.The unit passed all functional and safety tests and was returned to customer.
 
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Brand Name
CARDIOSAVE HYBRID, TYPE B 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 Key18963684
MDR Text Key338454212
Report Number2249723-2024-01232
Device Sequence Number1
Product Code DSP
UDI-Device Identifier10607567108391
UDI-Public10607567108391
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K112372
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 03/21/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/22/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number0998-00-0800-53
Device Catalogue Number0998-00-0800-53
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/13/2024
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
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