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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 Inaccurate Synchronization (1609)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/18/2019
Event Type  malfunction  
Manufacturer Narrative
The production device history record (dhr) for this iabp unit cannot be reviewed per the sop since the serial number for the unit was not provided.A supplemental report will be submitted when additional information is made available.
 
Event Description
It was reported that the blood pressure readings/fiber optic pressure values on the cardiosave intra-aortic balloon pump (iabp) were questionable between the fiber optic catheter and the blood pressure monitoring system.It appears that this occurred during use on a patient, but this has not yet been confirmed.However, there was no adverse event reported.
 
Manufacturer Narrative
A getinge field service engineer (fse) has reported that he is finding it hard to obtain any further information regarding this complaint.The end user was questioning the difference between the blood pressure reading measured at the tip of the fiber optic balloon in comparison with a reading taken from the radial transducer in the arm, however, getinge sales/clinical support has explained the reasons for this to the customer and from all indications, this has satisfied them.All addition attempts to obtain further information have been unsuccessful, but if pertinent information is received in the future, a supplemental report will be submitted.
 
Event Description
It was reported that the blood pressure readings/fiber optic pressure values on the cardiosave intra-aortic balloon pump (iabp) were questionable between the fiber optic catheter and the blood pressure monitoring system.It appears that this occurred during use on a patient, but this has not yet been confirmed.However, there was no adverse event 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 Key8876015
MDR Text Key186331613
Report Number2249723-2019-01245
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 11/08/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/08/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number0998-00-0800-52
Device Lot NumberN/A
Was Device Available for Evaluation? No
Date Manufacturer Received10/18/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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