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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID, TYPE I PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID, TYPE I PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number 0998-00-0800-45
Device Problem Connection Problem (2900)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/18/2021
Event Type  malfunction  
Event Description
It was reported that before use during a routine check it was observed that the power cord on the cardiosave intra-aortic balloon pump (iabp) was stuck inside the machine and could not be pulled out. There was no patient involvement, and no adverse event reported.
 
Manufacturer Narrative
Device not accessible for testing: (4117/213): at this time, the customer has not requested for getinge to evaluate the iabp unit involved in this event. A getinge representative has conversed with the customer and was advised that the customer resolved the issue by disassembling and reassembling the cord. The unit passed all functional and safety test per factory specifications. 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 event site name is (b)(6) hospital.
 
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Brand NameCARDIOSAVE HYBRID, TYPE I 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 Key13011805
MDR Text Key285738162
Report Number2249723-2021-02878
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K112372
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Nurse Practitioner
Type of Report Initial
Report Date 12/15/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/15/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number0998-00-0800-45
Device Catalogue Number0998-00-0800-45
Device Lot NumberN/A
Was Device Available for Evaluation? No
Date Manufacturer Received11/24/2021
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Type of Device Usage Reuse

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