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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 Output Problem (3005)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/18/2023
Event Type  malfunction  
Manufacturer Narrative
A supplemental report will be submitted upon completion of our investigation.
 
Event Description
It was reported that during inspection, the cardiosave intra-aortic balloon pump (iabp) unit has drive manifold leak error.There was no patient involvement.
 
Manufacturer Narrative
A getinge field service engineer (fse) was dispatched to investigate the issue.The fse replaced the drive manifold assembly.The fse completed the inspection with good results.
 
Event Description
N/a.
 
Manufacturer Narrative
The failure analysis and testing dept.Received part number 0104-00-0031 rev.J, serial number (b)(6) with a reported unit failure of a drive manifold leak error.The fat performed a visual inspection and found the part to be in good condition.The fat installed the manifold in cardiosave test fixture and tested the part to factory specifications per the cardiosave service manual.Confirmed that the part failed the drive manifold leak test.No root cause defined.Sending the board to the supplier for failure analysis per procedure.
 
Event Description
N/a.
 
Manufacturer Narrative
**udi related data quality updates only** providing updated device identification information in alignment with gudid.
 
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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.
1300 macarthur blvd
mahwah NJ
Manufacturer Contact
arelean guzman
1300 macarthur blvd
mahwah, NJ 
MDR Report Key18415120
MDR Text Key331583158
Report Number2249723-2023-05514
Device Sequence Number1
Product Code DSP
UDI-Device Identifier10607567108391
UDI-Public10607567108391
Combination Product (y/n)N
Reporter Country CodeJA
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 Biomedical Engineer
Type of Report Initial,Followup,Followup
Report Date 08/08/2024
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 Number0998-00-0800-53
Device Catalogue Number0998-00-0800-53
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/18/2023
Initial Date FDA Received12/28/2023
Supplement Dates Manufacturer Received05/16/2024
08/08/2024
Supplement Dates FDA Received05/17/2024
08/08/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/27/2016
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
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