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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. CARDIOSAVE RESCUE; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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DATASCOPE CORP. CARDIOSAVE RESCUE; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number 0998-00-0800-83
Device Problem Display or Visual Feedback Problem (1184)
Patient Problem Insufficient Information (4580)
Event Date 01/18/2021
Event Type  malfunction  
Event Description
Attempted to connect patient to transport iabp (intra-aortic balloon pump) and received an "auto-fill failure" error message.This is the same message that was received during the most recent iabp failure 3 weeks prior.Patient was able to be transported without incident on hospital iabp by ground ambulance (amr).Air care 1 iabp.Per getinge service tech: fault found during repair service.Replaced drive regulator.Unit passed all tests, returned to service.After assessing the patient, the transport iabp was placed on the patient "auto-fill failure" was noted on the iabp screen.Iabp was shut off and restarted, again iabp screen showed "auto-fill failure".The flight crew transported the patient to facility via ground ems without incident and took referring facility's iabp with them.
 
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Brand Name
CARDIOSAVE RESCUE
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP.
15 law drive
fairfield NJ 07004
MDR Report Key12134448
MDR Text Key260474015
Report Number12134448
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 06/24/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/08/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number0998-00-0800-83
Device Catalogue Number0998-00-0800-83
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/24/2021
Event Location Hospital
Date Report to Manufacturer07/08/2021
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age23725 DA
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