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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 10/17/2021
Event Type  malfunction  
Manufacturer Narrative
A getinge field service engineer (fse) was dispatched to evaluate this unit.Repairs are still ongoing and unit has not been cleared for clinical use and returned to customer.A supplemental report will be submitted when additional information is provided and/or our investigation is completed.The initial reporter named in is a getinge employee whose contact details differ from that of the event site.A contact at the event site is: (b)(6).
 
Event Description
It was reported that the cardiosave intra-aortic balloon pump (iabp) alarm continuously sounded while unit was off, until the battery was removed.Unit was not in use and in standby mode.There was no patient involvement, and no adverse event was reported.
 
Manufacturer Narrative
Testing of actual/suspected device(10, 3233) a getinge field service engineer (fse) was dispatched to evaluate this unit.Repairs are ongoing and the iabp unit remains at the customer¿s facility out of service.A supplemental report will be submitted when additional information is provided and/or our investigation is completed.
 
Event Description
It was reported that the cardiosave intra-aortic balloon pump (iabp) alarm continuously sounded while unit was off, until the battery was removed.Unit was not in use and in standby mode.There was no patient involvement, and no adverse event was reported.
 
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Brand Name
CARDIOSAVE HYBRID, TYPE G 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 Key12794239
MDR Text Key281910101
Report Number2249723-2021-02596
Device Sequence Number1
Product Code DSP
UDI-Device Identifier10607567108438
UDI-Public10607567108438
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,User Facility,Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup,Followup
Report Date 03/15/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/11/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number0998-00-0800-52
Device Catalogue Number0998-00-0800-52
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Date Manufacturer Received03/14/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/22/2021
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
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