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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID, TYPE G PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID, TYPE G PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number 0998-00-0800-52
Device Problem Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/02/2024
Event Type  malfunction  
Event Description
It was reported that during refresher training in the cath lab performed by a getinge service territory manager (stm), the cardiosave intra-aortic balloon pump (iabp) sounded like it was leaking.There was no patient involvement.
 
Manufacturer Narrative
A supplemental report will be submitted upon completion of our investigation.E1 event site telephone was shortened due to character limitations.The complete number is (b)(6).
 
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Brand Name
CARDIOSAVE HYBRID, TYPE G 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 Key19094981
MDR Text Key340743621
Report Number2249723-2024-01501
Device Sequence Number1
Product Code DSP
UDI-Device Identifier10607567108438
UDI-Public10607567108438
Combination Product (y/n)N
Reporter Country CodeEI
PMA/PMN Number
K112372
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 04/09/2024
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 Number0998-00-0800-52
Device Catalogue Number0998-00-0800-52
Initial Date Manufacturer Received 04/02/2024
Initial Date FDA Received04/12/2024
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
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