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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID TYPE I PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID TYPE I PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number 0998-00-0800-45
Device Problem Power Problem (3010)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/19/2021
Event Type  malfunction  
Manufacturer Narrative
Testing of actual/suspected device: the distributor's engineer evaluated this unit and was able to reproduce the reported issue. The power module of the frame (cart bulk power supply) was replaced and the issue was resolved. Unit passed all functional and safety test per factory specifications. The iabp was released to the customer and cleared for clinical service. A supplemental report will be submitted when the investigation is completed.
 
Event Description
It was reported that during the end user's boot check, the cardiosave intra-aortic balloon pump (iabp) cannot be booted normally and ac power cannot be used. There was no patient involvement, and no adverse event reported.
 
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Brand NameCARDIOSAVE HYBRID TYPE I 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 Key12350929
MDR Text Key267672297
Report Number2249723-2021-01886
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeCH
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
Report Date 08/19/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/20/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number0998-00-0800-45
Device Catalogue Number0998-00-0800-45
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 Received07/30/2021
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Reuse

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