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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 Temperature Problem (3022)
Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
Event Date 06/05/2019
Event Type  malfunction  
Manufacturer Narrative
The production device history record (dhr) for this intra-aortic balloon pump (iabp) was not required to be reviewed per company standard operating procedure since the device manufacture date is greater than one year from the event date.A getinge field service engineer (fse) evaluated the iabp unit and was unable to reproduce the reported issue.Since the reported issue was found recorded in the error history log, the fse replaced the compressor scroll along with the temperature sensor.All functional and safety tests were passed to meet factory specifications and the iabp was returned to the customer and cleared for clinical service.The full name of the event site name has been abbreviated due to field character limit; the full name should read (b)(6).
 
Event Description
It was reported that during use on a patient, the cardiosave intra-aortic balloon pump (iabp) was showing a "system over temperature" alarm.The iabp unit was restarted and it started working.However, the message appeared 3 times.No patient harm or adverse event was reported.
 
Event Description
It was reported that during use on a patient, the cardiosave intra-aortic balloon pump (iabp) was showing a "system over temperature" alarm.The iabp unit was restarted and it started working.However, the message appeared 3 times.No patient harm or adverse event was reported.
 
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Brand Name
CARDIOSAVE HYBRID
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ 07430
MDR Report Key8744398
MDR Text Key149510395
Report Number2249723-2019-01034
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,foreig
Type of Report Initial,Followup
Report Date 10/07/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/28/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number0998-00-0800-45
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Date Manufacturer Received10/07/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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