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U.S. Department of Health and Human Services

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

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DATASCOPE MAHWAH CARDIOSAVE; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0998-00-0800-53
Device Problems Circuit Failure (1089); Leak/Splash (1354)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/25/2017
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 and confirmed the problem stated by the customer, unit was leaking 45psi of the 65psi allowable tolerance.Troubleshot the unit per service manual and found the leak to be in cart and not in the console.Fse started by replacing the gasket on the helium cylinder, found the leak was persistent, replaced the high pressure regulator, high pressure transducer o-ring, and quick disconnect o-ring, lubed all connections with vacuum grease, reassembled the unit and ran leak test.Leak test passed with a tolerable pressure of 2 psi out of 65 psi allowable pressure.Fse reassembled the unit and completed all functional test and calibrations, unit has passed all test and is now ready for clinical use.
 
Event Description
The customer reported that the circuit leak in the intra-aortic balloon pump (iabp).The circumstances under which this event occurred is unknown.No information regarding patient involvement.However, no adverse event was reported.
 
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Brand Name
CARDIOSAVE
Type of Device
SYSTEM, 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 Key6798618
MDR Text Key83018099
Report Number2249723-2017-00298
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 Other
Type of Report Initial
Report Date 08/16/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number0998-00-0800-53
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Device AgeYR
Initial Date Manufacturer Received 07/25/2017
Initial Date FDA Received08/16/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/01/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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