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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 Failure to Sense (1559)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/20/2021
Event Type  malfunction  
Manufacturer Narrative
Testing of actual/suspected device: a getinge field service engineer (fse) was dispatched to investigate and evaluate the iabp unit.The fse was informed that the customer replaced the touchscreen which did not resolve the issue.After further troubleshooting, the fse found that there was not another touchscreen panel.However, the fse found that the safety disk leak test, as well as the drive assembly test were also failing.Therefore, the fse resolved the issues by replacing the drive assembly, and also replaced the defective pneumatic module cable and reseated it to the backplane.The fse performed calibration, functional and safety checks to meet factory specifications, without any further failures.The iabp was then released to the customer and cleared for clinical service.A supplemental report will be submitted upon completion of our investigation.The full name of the initial reporter that is abbreviated is (b)(6).
 
Event Description
During a preventative maintenance (pm) service repair performed by a getinge field service engineer (fse), the customer reported to the fse that the touch panel of the cardiosave intra-aortic balloon pump (iabp) was not working properly, where it did not allow 30 psi pressure calibration to complete.It is unknown the circumstances under which the event occurred.However, there was no patient involvement, and no adverse event reported.
 
Event Description
N/a.
 
Manufacturer Narrative
Updated fields: b4, g4, g7, g8, h2, h4, h6 (type of investigation, investigation findings, investigation conclusions), h10, h11 corrected field: d5, e1 (initial reporter, event site telephone, event site email), e2, e3, e4, g1 (contact person ¿ mfg site), g3 (health professional, user facility should not be included).The initial reporter named in block e1 is a getinge employee who has different contact details from that of the event site.A contact person at the event site is (b)(6), biomedical engineer.
 
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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 Key12606811
MDR Text Key280158506
Report Number2249723-2021-02321
Device Sequence Number1
Product Code DSP
UDI-Device Identifier10607567108391
UDI-Public10607567108391
Combination Product (y/n)N
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 Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 08/01/2022
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 Other
Device Model Number0998-00-0800-53
Device Catalogue Number0998-00-0800-53
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 09/20/2021
Initial Date FDA Received10/11/2021
Supplement Dates Manufacturer Received08/01/2022
Supplement Dates FDA Received08/02/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/11/2018
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
Treatment
N/A.
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