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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 Problems Communication or Transmission Problem (2896); Unexpected Shutdown (4019)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/24/2021
Event Type  malfunction  
Manufacturer Narrative
Testing of actual/suspected device(10,3213) a getinge field service engineer (fse) was dispatched to evaluate this unit. Customer stated the system would display a communication error and shut down. Fse observed system and entered log for insight to troubleshooting. Error log indicated drive transducer failure. Fse replaced drive transducer. During testing system would not pass 30 psi calibration. Fse troubleshooted system and determined the pim assembly was defective. Fse returned with pim module and replaced assembly. The fse completed all safety, functionality, and calibration checks and all tests passed to factory specifications. The iabp unit was cleared for clinical use and released to the customer. A supplemental report will be submitted upon completion of our investigation the full name of the event site was shortened due to field character limit; the full name is (b)(6).
 
Event Description
It was reported that the cardiosave intra-aortic balloon pump (iabp) had communication error 21. It is unknown under which circumstances this event occurred; however there was no patient involvement, and no adverse event was reported. Communication error 21.
 
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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
brian schaeffer
1300 macarthur blvd
mahwah, NJ 
MDR Report Key12651471
MDR Text Key281342179
Report Number2249723-2021-02378
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 Health Professional,User Facility,Company Representative
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup,Followup
Report Date 04/22/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/18/2021
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? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/30/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/31/2018
Is the Device Single Use? No
Type of Device Usage Reuse

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