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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID, TYPE I PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID, TYPE I PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number 0998-00-0800-45
Device Problem Gas/Air Leak (2946)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/04/2024
Event Type  malfunction  
Manufacturer Narrative
A supplemental report will be submitted upon completion of our investigation.E1 event site name was shortened due to character limitations.The complete name is the (b)(6) hospital.E1.Event site telephone was shortened due to character limitations.The complete number is: (b)(6).
 
Event Description
It was reported the cardiosave intra-aortic balloon pump (iabp) had iab loop air leakage.The unit was immediately switched for another to continue therapy.There was no harm reported.
 
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Brand Name
CARDIOSAVE HYBRID, TYPE I 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 Key18916558
MDR Text Key337811655
Report Number2249723-2024-01125
Device Sequence Number1
Product Code DSP
UDI-Device Identifier10607567108421
UDI-Public10607567108421
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K112372
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
Report Date 03/12/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/15/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number0998-00-0800-45
Device Catalogue Number0998-00-0800-45
Date Manufacturer Received03/04/2024
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
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