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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 N/A
Device Problem Unexpected Shutdown (4019)
Patient Problems Myocardial Infarction (1969); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/14/2021
Event Type  Death  
Manufacturer Narrative
A supplemental report will be submitted when additional information is provided.
 
Event Description
It was reported that during patient therapy, the cardiosave intra-aortic balloon pump (iabp) screen went black and then unit suddenly shutdown, after the unit alarmed "gas loss in iab circuit. " it was further reported that the iabp unit was connected to the ac mains power supply when this reported issue occurred. Additionally and unrelated, it was reported that the iabp unit alarmed ¿gas gain in iab circuit. ¿ 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
dorota wolpiuk
1300 macarthur blvd
mahwah, NJ 
MDR Report Key11654968
MDR Text Key245088738
Report Number2249723-2021-00761
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeNL
PMA/PMN Number
K112372
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 05/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/13/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number0998-00-0800-55
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/22/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/07/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 04/13/2021 Patient Sequence Number: 1
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