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U.S. Department of Health and Human Services

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

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DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number N/A
Device Problem Failure to Sense (1559)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/09/2020
Event Type  malfunction  
Manufacturer Narrative
A getinge field service engineer (fse) evaluated the iabp unit and found error in logs and that the fiber optic sensor (fos) continuous bit failed. The fse replaced the fiber optic sensor assembly per the service manual. The biomed catheter/ fos cable on the unit, and it failed. The fse determined the fos catheter was defective by testing it on another unit. The fse performed full calibration, functional and safety checks 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.
 
Event Description
It was reported that during use on a patient, the cardiosave intra-aortic balloon pump (iabp) had fiber optic sensor failure. Pump and catheter were exchanged without issue. No patient harm, serious injury or adverse event was reported.
 
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Brand NameCARDIOSAVE HYBRID
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ 07430
Manufacturer (Section G)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ 07430
Manufacturer Contact
dorota wolpiuk
1300 macarthur blvd
mahwah, NJ 07430
MDR Report Key11097959
MDR Text Key226016855
Report Number2249723-2020-02259
Device Sequence Number1
Product Code DSP
UDI-Device Identifier10607567108421
UDI-Public10607567108421
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K112372
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/27/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/30/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
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 Received12/30/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/01/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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