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U.S. Department of Health and Human Services

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

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DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID, TYPE G PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number 0998-00-0800-52
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/01/2022
Event Type  malfunction  
Manufacturer Narrative
A getinge field service engineer (fse) evaluated the iabp unit and the safety disk was replaced and unit passed all manifold test. The fse performed all functional and safety checks to meet factory specifications. 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 initial reporter named in block e1 is a getinge employee who has different contact details from that of the event site. A contact person at the event site is (b)(6).
 
Event Description
It was reported that the cardiosave intra-aortic balloon pump (iabp) after being fixed and replacing the pcba video generator, the all manifold membrane test failed. There was no patient involvement, and no adverse event reported.
 
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Brand NameCARDIOSAVE HYBRID, TYPE G 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 Key14239389
MDR Text Key290467401
Report Number2249723-2022-00956
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeSN
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 Non-Healthcare Professional
Type of Report Initial
Report Date 04/26/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/28/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number0998-00-0800-52
Device Catalogue Number0998-00-0800-52
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Date Manufacturer Received04/01/2022
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Type of Device Usage Reuse

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