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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID INT TYPE E/F PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID INT TYPE E/F PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number 0998-00-0800-55 -
Device Problem Connection Problem (2900)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/01/2022
Event Type  malfunction  
Event Description
It was reported that during use the cardiosave intra-aortic balloon pump (iabp) unit's ecg plug extension input has temporary interruptions of the input signal. No patient harm, serious injury or adverse event was reported.
 
Manufacturer Narrative
Testing of actual/suspected device a getinge field service engineer (fse) was dispatched to investigate. The fse evaluated the cardiosave intra-aortic balloon pump (iabp) unit and found that the ecg jack input contacts needed to be corrected and cleaned. The fse performed functional and safety checks to meet 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.
 
Manufacturer Narrative
A getinge field service engineer (fse) was dispatched to investigate. The fse evaluated the cardiosave intra-aortic balloon pump (iabp) unit and found that the ecg jack input contacts needed to be corrected and cleaned. The fse performed functional and safety checks to meet 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.
 
Event Description
It was reported that during use the cardiosave intra-aortic balloon pump (iabp) unit's ecg plug extension input has temporary interruptions of the input signal. No patient harm, serious injury or adverse event was reported.
 
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Brand NameCARDIOSAVE HYBRID INT TYPE E/F 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 Key13544243
MDR Text Key285705026
Report Number2249723-2022-00308
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeGM
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
Type of Report Initial
Report Date 02/15/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/16/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number0998-00-0800-55 -
Device Catalogue Number0998-00-0800-55
Device Lot NumberN/A
Was Device Available for Evaluation? No
Date Manufacturer Received02/01/2022
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Type of Device Usage Reuse

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