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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 Charge (1085); Device Sensing Problem (2917)
Patient Problem No Patient Involvement (2645)
Event Date 07/16/2018
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 getinge 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 investigate. The fse evaluated the iabp unit and adjusted the optic switch. The fse performed an autofill and let machine pump to ensure proper function. The iabp passed all testing to factory specifications and was cleared for clinical use.
 
Event Description
It was reported that the optic switch of the cs300 intra-aortic balloon pump (iabp) needed adjusting. The batteries were not charging and the cart was not recognizing that the unit was plugged into it. This event occurred prior to use on a patient. There was no patient involvement, thus no adverse event was reported.
 
Manufacturer Narrative
A getinge field service engineer (fse) was dispatched to investigate. The fse evaluated the iabp unit and determined that the cart was not recognizing that the unit was plugged into it; therefore, the batteries were not charging. The fse adjusted the optic switch, performed an autofill and let machine pump to ensure proper function. The fse completed a preventative maintenance (pm) with full calibration, functional testing and safety checks to factory specifications. The iabp passed all testing to factory specifications and was cleared for clinical use.
 
Event Description
It was reported that the optic switch of the cs300 intra-aortic balloon pump (iabp) needed to be adjusted. This event occurred prior to use on a patient. There was no patient involvement, 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 Key7769019
MDR Text Key116874367
Report Number2249723-2018-01350
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,Followup
Report Date 09/11/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/09/2018
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? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/21/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/01/2016
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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