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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE MAHWAH CARDIOSAVE HYBRID; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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DATASCOPE MAHWAH CARDIOSAVE HYBRID; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number N/A
Device Problem Infusion or Flow Problem (2964)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/04/2019
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 the company standard operating procedure since the device manufacture date is greater than one year from the event date.A getinge field service engineer (fse) was dispatched to evaluate this unit and replaced the helium tank.Additionally, upon evaluation of the iabp itself, the fse found that the internal helium tank pressure dropped by approximately 150 psi in a 5-minute period.To confirm if there were leaking points, the fse applied "gas leak check liquid spray" on the surface of the unit and tubing connections inside the unit and on the hospital cart and was able to identify the leaking point.The fse then disassembled parts of the fill manifold (cv1) and found that the o-ring was damaged.To resolve the issue, the fse replaced the o-ring.However, the iabp is still under observation and has not been released for clinical use.A supplemental report will be submitted upon completion of evaluation.
 
Event Description
The customer reported that during a preventative maintenance they found that the helium tank of the cardiosave intra-aortic balloon pump (iabp) was almost empty even though the iabp had not been used recently and the helium tank was closed.There was no patient involvement and no adverse event was reported.
 
Event Description
The customer reported that during a preventative maintenance they found that the helium tank of the cardiosave intra-aortic balloon pump (iabp) was almost empty even though the iabp had not been used recently and the helium tank was closed.There was no patient involvement and no adverse event was reported.
 
Manufacturer Narrative
A getinge representative has advised that the repair has been fully completed and that the getinge field service engineer (fse) found no abnormalities after the o-ring was replaced.The unit was cleared for clinical use after passing all functional and safety checks per factory specifications.
 
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Brand Name
CARDIOSAVE HYBRID
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE MAHWAH
1300 macarthur blvd.
mahwah NJ 07430
MDR Report Key8376146
MDR Text Key138165784
Report Number2249723-2019-00314
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 04/03/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/27/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberN/A
Device Catalogue Number0998-00-0800-53
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Device Age YR
Date Manufacturer Received03/08/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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