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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 Device Displays Incorrect Message (2591)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/27/2021
Event Type  malfunction  
Event Description
It was reported that during patient use the cardiosave intra-aortic balloon pump (iabp) was showing "gas loss in iab circuit", the customer advised that when taking the patient to a ct scan they removed the unit from the hospital cart, when the unit was removed from the cart they confirmed that the helium tank was full. The pressure of the helium cylinder dropped to half. No patient harm, serious injury or adverse event was reported.
 
Manufacturer Narrative
A getinge field service engineer (fse) evaluated the iabp unit but was unable to reproduce the reported issue of "gas loss alarm". He reviewed the logs, ran the unit on rescue mode with the balloon for testing, and also passed the all manifold test. He then 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. (b)(6).
 
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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
arelean guzman
1300 macarthur blvd
mahwah, NJ 
MDR Report Key13100633
MDR Text Key285051075
Report Number2249723-2021-02967
Device Sequence Number1
Product Code DSP
UDI-Device Identifier10607567108438
UDI-Public10607567108438
Combination Product (y/n)N
Reporter Country CodeHK
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,Followup
Report Date 08/07/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/28/2021
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
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/07/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/09/2016
Is the Device Single Use? No
Type of Device Usage Reuse

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