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U.S. Department of Health and Human Services

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

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DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID, TYPE G PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number 0998-00-0800-52
Device Problem Unable to Obtain Readings (1516)
Patient Problems Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/09/2021
Event Type  malfunction  
Event Description
It was reported that during use on a patient, the screen for the cardiosave intra-aortic balloon pump (iabp) was not showing the signals while operating. The end user swapped out the iabp unit with another iabp unit to continue therapy without issue. There was no patient harm and no adverse event was reported.
 
Manufacturer Narrative
A getinge field service engineer (fse) was dispatched to evaluate this unit. The fse observed several fault code #107 (isolation dsp cbit failure shut down fault) logged in the iabp log files. The fse completed all safety, functionality, and calibration checks and all tests passed to factory specifications. However, it was observed that the safety disk and tidal disk were due for replacement. Suggestions to the customer have been made to replace both items and a supplemental report will be submitted if additional information is provided. The status of the iabp unit is unknown.
 
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Brand NameCARDIOSAVE HYBRID, TYPE G 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
brian schaeffer
1300 macarthur blvd
mahwah, NJ 
MDR Report Key12564967
MDR Text Key280942976
Report Number2249723-2021-02232
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeSN
PMA/PMN Number
K112372
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 02/01/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/01/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number0998-00-0800-52
Device Catalogue Number0998-00-0800-52
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received01/10/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/13/2015
Is the Device Single Use? No
Type of Device Usage Reuse

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