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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 Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/05/2021
Event Type  malfunction  
Manufacturer Narrative
A supplemental report will be submitted when additional information is provided.
 
Event Description
It was reported that the lcd display of the cardiosave intra-aortic balloon pump (iabp) was broken.It is unknown the circumstances under which the event occurred.It is also unknown if there was a patient involvement.However, there was no adverse event reported.
 
Manufacturer Narrative
Updated fields; b4, g3, g6, g7, h2, h3, h4, h6, h10, h11.Corrected fields: g1.A getinge technician was not dispatched to evaluate the unit because the customer reported that the unit has not been repaired because of parts delay.Good faith efforts (gfe) attempts were made to the customer to obtain additional information on this complaint event.The customer provided partial information and stated not to be contacted anymore.Not related to the reported issue, a getinge field service engineer (fse) performed a full scheduled preventive maintenance with all calibration, functional and safety checks to meet factory specifications.Unit passed all calibration, functional and safety test per factory specifications.The pm was completed and the iabp was then released to the customer and cleared for clinical service.
 
Event Description
N/a.
 
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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 Key12706728
MDR Text Key281286927
Report Number2249723-2021-02477
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 Biomedical Engineer
Type of Report Initial,Followup
Report Date 11/08/2022
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
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/05/2021
Initial Date FDA Received10/27/2021
Supplement Dates Manufacturer Received11/07/2022
Supplement Dates FDA Received11/08/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/27/2012
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
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