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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 Device Contamination with Body Fluid (2317)
Patient Problem Insufficient Information (4580)
Event Type  malfunction  
Event Description
It was reported that the cardiosave intra-aortic balloon pump (iabp) had blood back into the pump.
 
Manufacturer Narrative
A getinge service territory manager (stm) was dispatched to investigate.The stm found little to no traces of blood in unit.Replaced the pneumatic module assy (pim) (0997-00-1178) and pim cable to backplane (0012-00-1640) as precautionary measures.Reassembled the unit and performed a full pm per manufacture specifications, unit has passed all test and calibrations and iabp was returned to the customer, now ready for clinical use.This report is being submitted as the result of a retrospective review conducted in capa (b)(4).
 
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Brand Name
CARDIOSAVE HYBRID, TYPE B PLUG
Type of Device
SYSTEM, 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
arelean guzman
1300 macarthur blvd
mahwah, NJ 
MDR Report Key16075271
MDR Text Key308490178
Report Number2249723-2022-03522
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 Other Health Care Professional
Type of Report Initial
Report Date 10/28/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/29/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number0998-00-0800-53
Device Catalogue Number0998-00-0800-53
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/27/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/25/2017
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
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