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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID TYPE E/F PLG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID TYPE E/F PLG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number 0998-00-0800-55
Device Problem Unexpected Shutdown (4019)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/27/2021
Event Type  malfunction  
Manufacturer Narrative
The full name of the initial reporter is (b)(6). Testing of actual/suspected device: a getinge field service engineer (fse) was dispatched to evaluate the iabp and was able to reproduce the reported issue. The fse determined that the machine cannot run to functional display, checked alarm event log in service mode found fault code 118 "sol wdt fail" and "fault code 139 pmb communication error". To fix the issue, the fse replaced the solenoid control pcb and the power management pcb. All functional and safety checks were performed to meet factory specifications. Unit passed all calibration, functional and safety test per factory specifications. The iabp was then released to the customer and cleared for clinical service. A supplemental report will be submitted upon completion of our investigation.
 
Event Description
It was reported that during use on a patient, the cardiosave intra-aortic balloon pump (iabp) shutdown, did not run to functional display (show reload display all time), and beeped afterwards. The unit was swapped out with another to continue therapy. No patient harm, serious injury or adverse event was reported.
 
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Brand NameCARDIOSAVE HYBRID TYPE E/F PLG
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
arelean guzman
1300 macarthur blvd
mahwah, NJ 
MDR Report Key12674144
MDR Text Key277719181
Report Number2249723-2021-02417
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeTH
PMA/PMN Number
K112372
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 07/27/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/21/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number0998-00-0800-55
Device Catalogue Number0998-00-0800-55
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Date Manufacturer Received07/27/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/15/2020
Is the Device Single Use? No
Type of Device Usage Reuse

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