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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE CORP. - MAHWAH; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Device Problem Failure to Charge (1085)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/21/2024
Event Type  malfunction  
Manufacturer Narrative
A supplemental report will be submitted upon completion of our investigation.
 
Event Description
It was reported that the cardiosave intra-aortic balloon pump (iabp) battery was not holding a charge.There was no patient involvement.
 
Event Description
It was reported that during routine check discovered by hospital personnel , the cardiosave intra-aortic balloon pump (iabp) battery was not holding a charge.There was no patient involvement.
 
Manufacturer Narrative
A getinge field service engineer (fse) confirmed the reported the reported issue during evaluation and installing a new set of batteries (0146-00-0039).A complete pm with full calibration, functional testing and safety check to factory specifications.The unit was returned to the customer and cleared for customer use.
 
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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 Key19052588
MDR Text Key339554875
Report Number2249723-2024-01410
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
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 04/15/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/21/2024
Initial Date FDA Received04/05/2024
Supplement Dates Manufacturer Received04/08/2024
04/15/2024
Supplement Dates FDA Received04/10/2024
04/15/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/03/2005
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
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