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U.S. Department of Health and Human Services

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

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DATASCOPE MAHWAH CARDIOSAVE HYBRID TYPE B SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number N/A
Device Problem Protective Measures Problem (3015)
Patient Problem No Patient Involvement (2645)
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 performed helium leak test and observed 45 psi leak in 5 minutes. The fse isolated leak to regulator low pressure line and reseated and corrected leak. The test passed with a control leak of 6psi in 5 minutes well below specifications of 20 psi in 5 minutes. The unit passed all functional and safety tests per factory specifications and was returned to customer and cleared for clinical use.
 
Event Description
It was reported that the customer expressed concern about helium depletion off the cardiosave intra-aortic balloon pump (iabp) that had been stored and not in use. The customer requested to have the unit checked for leaks. This event occurred during service by the customer. There was no patient involvement and no adverse event was reported.
 
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Brand NameCARDIOSAVE HYBRID TYPE B
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE MAHWAH
1300 macarthur blvd.
mahwah NJ 07430
Manufacturer (Section G)
DATASCOPE MAHWAH
1300 macarthur blvd.
mahwah NJ 07430
Manufacturer Contact
1300 macarthur blvd.
mahwah, NJ 07430
MDR Report Key8190527
MDR Text Key131341218
Report Number2249723-2018-02200
Device Sequence Number1
Product Code DSP
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 company representative,user f
Reporter Occupation
Type of Report Initial
Report Date 12/14/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/21/2018
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
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/03/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/01/2011
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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