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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 Appropriate Term/Code Not Available (3191)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 01/13/2022
Event Type  malfunction  
Manufacturer Narrative
Testing of actual/suspected device: a getinge field service engineer (fse) was dispatched to evaluate this unit. The customer stated that the device was not working and wave forms could not be seen. The fse tested the device per manufacturer specifications and was not able to duplicate the issue with wave forms. The fse connected the trainer and patient simulator and could not duplicate any failure with the wave forms. The fse verified the unit calibration and the unit passed all functional and safety tests per the factory specifications. The unit was returned to the customer and cleared for clinical use. A supplemental report will be submitted upon completion of our investigation. The first name of the initial reporter has been abbreviated due to field character limit; the full name should read (b)(6).
 
Event Description
It was reported that prior to use on patient the cardiosave intra-aortic balloon pump (iabp) was not working. There was no patient involvement, and no adverse event was 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
brian schaeffer
1300 macarthur blvd
mahwah, NJ 
MDR Report Key13459147
MDR Text Key287030049
Report Number2249723-2022-00227
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 User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/04/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/04/2022
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? No
Date Manufacturer Received02/07/2022
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Type of Device Usage Reuse

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