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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 Device Alarm System (1012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/02/2021
Event Type  malfunction  
Manufacturer Narrative
Testing of actual/suspected device (10/213): a getinge field service engineer (fse) evaluated the iabp and was able to verify issue, the unit powered up right when it was plugged in and then a loud audible alarm. To fix the issue, the fse replaced the power management board and the unit is working now. Safety, and functionality checks completed per the service manual and passed to the factory specifications. Returned for clinical service upon completion. A supplemental report will be submitted upon completion of our investigation.
 
Event Description
It was reported that the cardiosave intra-aortic balloon pump (iabp) had a high pitch alarm. There was no patient involvement, and no adverse event reported.
 
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Brand NameCARDIOSAVE HYBRID TYPE B 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 Key12362414
MDR Text Key267966608
Report Number2249723-2021-01895
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
PMA/PMN Number
K112372
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation
Type of Report Initial
Report Date 08/20/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/24/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number0998-00-0800-53
Device Catalogue Number0998-00-0800-53
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/02/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/29/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Reuse

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