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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
Model Number N/A
Device Problems Failure to Power Up (1476); Communication or Transmission Problem (2896); Computer Operating System Problem (2898)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/05/2018
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. Evaluation conclusion codes: cause traced to component failure, (b)(4). A getinge field service engineer (fse) was dispatched to evaluated the iabp unit. The fse moved the coiled cable and the iabp had a fatal alarm and shut down. The fse discovered on the corner of the monitor was damaged. The fse had to replace the damaged pinched cable from the lower to the upper display, the coiled cables, the cable tie, the cardiosave label, the inside badge, and the hinge cover. Unrelated to the complaint issue, the fse replaced the four screws on the video generator, because they were missing. After replacing the parts, the iabp unit was still did not powering up properly. To fix the issue, the fse replaced the executive processor board, and performed all functional and safety checks to meet factory specifications. The iabp was then released to the customer and cleared for clinical service.
 
Event Description
It was reported that during a routine check, the cardiosave intra-aortic balloon pump (iabp) would not complete boot up. The iabp has an internal communication failure. The blue circle on the screen keeps spinning. After several attempts, the iabp unit was able to power up. No patient was involved and 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 Key7726275
MDR Text Key115470143
Report Number2249723-2018-01267
Device Sequence Number0
Product Code DSP
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 07/27/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/27/2018
Is this a Product Problem Report? Yes
Device Operator
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 Received07/06/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/01/2013
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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