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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-XX
Device Problem Connection Problem (2900)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/19/2017
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 getinge standard operating procedure since the device manufacture date is greater than one year from the event date. The company representative from the business unit (bu) reported that they tried to fix the connection problem by adjusting the position of the ac and external connectors, but still the problem persisted. They tried to adjust locking metal by adjusting the plate. The company representative reported that the mentioned complaint has been rectified by adjusting the console chassis and lock in the cart. All preventative maintenance (pm) checks were performed and the iabp unit has passed all tests.
 
Event Description
It was reported that the intra-aortic balloon pump (iabp) ac and external helium tank connections are disconnecting from the cart intermittently while moving the device. In addition, the display is not showing ac even when the unit is connected to ac. The console needed to be removed and inserted again to reconnect the ac and external tank. This connection issue with ac and external tank is found during movement of cardiosave unit. This event occured before use on a patient, thus no adverse event was reported.
 
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Brand NameCARDIOSAVE
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 Key6786730
MDR Text Key82679239
Report Number2249723-2017-00262
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
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 08/10/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/10/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number0998-00-0800-XX
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Device AgeYR
Event Location No Information
Date Manufacturer Received07/19/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/01/2014
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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