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U.S. Department of Health and Human Services

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

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DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID TYPE B PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number N/A
Device Problems No Device Output (1435); Failure to Power Up (1476); Charging Problem (2892); Contamination /Decontamination Problem (2895)
Patient Problem No Patient Involvement (2645)
Event Date 04/08/2019
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 company standard operating procedure since the device manufacture date is greater than one year from the event date. The getinge field service engineer (fse) that discovered the issue replaced the power slot interface board; however this did not resolve the issue. The fse examined the iabp and found saline was spilled inside the iabp; the fse indicated that the spill might have caused component damage to the power management board, the fse order and replaced it. The fse reported that the iabp was experiencing power failure during compressor startup; to fix this issue the fse replaced the compressor, drive manifold, motor control board without solving the issue. The fse then replaced the backplane and this improved the condition of the iabp. However, the compressor would not turn on, to address this latest issue the fse replaced the motor control board. The fse then performed 30psi calibration and passed; the fse indicated that the printer was not working on the iabp, to fix this issue the fse replaced the printer interface. A full pm was performed and all functional and safety tests were performed and passed to meet factory specifications, and the iabp was returned to the customer and cleared for clinical service. A supplemental report will be submitted upon failure investigation completion by getinge's national repair center. (b)(6).
 
Event Description
It was reported that during the inspection of a demo cardiosave intra-aortic balloon pump (iabp) by a getinge field service engineer (fse) that the printer was not working and the battery slot two was not charging. Additionally, saline was found in the iabp and it was also experiencing power failure during compressor startup. There was no patient involvement and no adverse event was reported.
 
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Brand NameCARDIOSAVE HYBRID TYPE B PLUG
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ 07430
Manufacturer (Section G)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ 07430
Manufacturer Contact
1300 macarthur blvd
mahwah, NJ 07430
MDR Report Key8580156
MDR Text Key144163519
Report Number2249723-2019-00722
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K112372
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/08/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/03/2019
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
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Device AgeYR
Event Location No Information
Date Manufacturer Received09/19/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/01/2016
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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