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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID, TYPE B PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID, TYPE B PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number 0998-00-0800-53 - CARDIOSAVE HYBRID DOMESTIC
Device Problem No Audible Alarm (1019)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/18/2022
Event Type  malfunction  
Manufacturer Narrative
Testing of actual/suspected device|10: a getinge field service engineer (fse) evaluated the cardiosave intra-aortic balloon pump (iabp), but was unable to reproduce the reported issue.However, the fse verified all electrical connections and inspected and replaced the coiled cord to display as a precautionary measure.The fse performed all functional and safety checks to meet factory specifications.The iabp was then released to the customer for return to clinical service.A supplemental report will be submitted upon completion of our investigation.The full name of the initial reporter is (b)(6).
 
Event Description
It was reported by the customer during power up the cardiosave intra-aortic balloon pump (iabp) unit displayed an alarm.There was no patient involvement, and no adverse event reported.
 
Manufacturer Narrative
Testing of actual/suspected device|10: a getinge field service engineer (fse) evaluated the cardiosave intra-aortic balloon pump (iabp), but was unable to reproduce the reported issue.However, the fse verified all electrical connections and inspected and replaced the coiled cord to display as a precautionary measure.The fse performed all functional and safety checks to meet factory specifications.The iabp was then released to the customer for return to clinical service.A supplemental report will be submitted upon completion of our investigation.The full name of the initial reporter is (b)(6).
 
Event Description
It was reported by the customer during power up the cardiosave intra-aortic balloon pump (iabp) unit displayed an alarm.There was no patient involvement, and no adverse event reported.
 
Manufacturer Narrative
A getinge field service engineer (fse) evaluated the cardiosave intra-aortic balloon pump (iabp), but was unable to reproduce the reported issue.However, the fse verified alarm codes 111, 112 and 118 in the logs and also verified all electrical connections and inspected and replaced the coiled cord to display as a precautionary measure.The fse performed all functional and safety checks to meet factory specifications.The iabp was then released to the customer for return to clinical service.A supplemental report will be submitted upon completion of our investigation.
 
Event Description
It was reported that during daily testing when powered on the cardiosave intra-aortic balloon pump (iabp) unit sounded an alarm.There was no patient involvement, and no adverse event reported.
 
Event Description
N/a.
 
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Brand Name
CARDIOSAVE HYBRID, TYPE B 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 Key13480697
MDR Text Key285237748
Report Number2249723-2022-00239
Device Sequence Number1
Product Code DSP
UDI-Device Identifier10607567108391
UDI-Public10607567108391
Combination Product (y/n)N
PMA/PMN Number
K112372
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup,Followup
Report Date 03/26/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/08/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number0998-00-0800-53 - CARDIOSAVE HYBRID DOMESTIC
Device Catalogue Number0998-00-0800-53
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/01/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/28/2015
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
Treatment
N/A.
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