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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 Loose or Intermittent Connection (1371)
Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/02/2024
Event Type  malfunction  
Manufacturer Narrative
A supplemental report will be submitted upon completion of our investigation.E1 event site telephone was shortened due to character limitations.The complete phone number is (b)(6).
 
Event Description
It was reported that the cardiosave intra-aortic balloon pump (iabp) the doppler cable would not attach.
 
Event Description
It was reported that during preventative maintenance by getinge field service engineer, the cardiosave intra-aortic balloon pump (iabp) the doppler cable would not attach.There was no patient involvement.
 
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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 Key18691258
MDR Text Key335309940
Report Number2249723-2024-00602
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUK
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 Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 02/22/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/12/2024
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
Date Manufacturer Received02/21/2024
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
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