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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
Device Problem Communication or Transmission Problem (2896)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/23/2022
Event Type  malfunction  
Event Description
It was reported that the cardiosave intra-aortic balloon pump (iabp) had a fault code 67 error.It is unknown the circumstances under which the event occurred.However, there was no patient involvement, and no adverse event reported.
 
Manufacturer Narrative
The facility biomed called to cancel the requested service indicating that they had corrected the issue.Additional information is being requested with regard to the repair and status of the iabp.A supplemental report will be submitted upon completion of our investigation.No service requested.
 
Manufacturer Narrative
A getinge fields service engineer (fse) has reported that the iabp unit is functional and was cleared for clinical use.A supplemental report will be submitted upon completion of our investigation.
 
Event Description
N/a.
 
Manufacturer Narrative
It was reported that the cardiosave intra-aortic balloon pump (iabp) had a fault code 67 error.It is unknown the circumstances under which the event occurred.However, there was no patient involvement, and no adverse event reported.A getinge field service engineer (fse) stated that biomedical technician amanda hirst called, an canceled service call, stated they had corrected the issue by replacing the blood pressure transducer adapter cable.No service provided.Unit functional cleared for customer use.No fault found.
 
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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 Key14140901
MDR Text Key289495093
Report Number2249723-2022-00891
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,Company Representative
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup,Followup
Report Date 04/01/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/19/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number0998-00-0800-53
Device Catalogue Number0998-00-0800-53
Device Lot NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/30/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured12/29/2015
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
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