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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 Connection Problem (2900)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/16/2021
Event Type  malfunction  
Manufacturer Narrative
A getinge field service engineer (fse) evaluated the iabp unit, and replaced the fiber optic connector assembly but he could not get the tester to run the test. The fse then returned the following day with a different fiber optic connector assembly, and replaced it. The fse then calibrated the iabp to factory specifications and ran multiple fiber optic tests. All functional and safety checks to meet factory specifications were performed. The iabp was then released to the customer for return to clinical service.
 
Event Description
It was reported that prior to use, the cardiosave intra-aortic balloon pump (iabp) was not able to connect with the fiber optic. There was no patient involvement, and no adverse event reported.
 
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Brand NameCARDIOSAVE HYBRID TYPE B PLUG
Type of DeviceSYSTEM, 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
dorota wolpiuk
1300 macarthur blvd
mahwah, NJ 
MDR Report Key11637585
MDR Text Key244622996
Report Number2249723-2021-00733
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
PMA/PMN Number
K112372
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 06/18/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/08/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
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
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/15/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/06/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Reuse

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