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U.S. Department of Health and Human Services

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

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DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID TYPE I (AU); SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number 0998-00-0800-31
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/19/2022
Event Type  malfunction  
Manufacturer Narrative
A supplemental report will be submitted upon completion of our investigation.
 
Event Description
It was reported that during preventive maintenance (pm) performed by a getinge service territory manager (stm) the cardiosave intra-aortic balloon pump (iabp) unit safety disk failed the membrane test.There was no patient involved.
 
Manufacturer Narrative
The getinge field service engineer (fse) that encountered the reported issue during the preventative maintenance (pm) replaced the safety disk as due for replacement, but the new safety disk failed the membrane test specifications.So, we install the old safety disk now and performed a full functional and safety checks to meet factory specifications.Unit passed all functional and safety test per factory specifications.The pm was completed and the iabp was then released and cleared for clinical service.
 
Event Description
N/a.
 
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Brand Name
CARDIOSAVE HYBRID TYPE I (AU)
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 Key15680267
MDR Text Key306998399
Report Number2249723-2022-02783
Device Sequence Number1
Product Code DSP
UDI-Device Identifier10607567109053
UDI-Public10607567109053
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K112372
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 02/20/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number0998-00-0800-31
Device Catalogue Number0998-00-0800-31
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 10/19/2022
Initial Date FDA Received10/27/2022
Supplement Dates Manufacturer Received02/19/2024
Supplement Dates FDA Received02/20/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/31/2014
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
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