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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE MAHWAH CS100 SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE MAHWAH CS100 SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number N/A
Device Problems Defective Device (2588); Output Problem (3005)
Patient Problem No Patient Involvement (2645)
Event Date 10/11/2018
Event Type  malfunction  
Manufacturer Narrative
The production device history record (dhr) for this intra-aortic balloon pump (iabp) was reviewed and no non-conformances related to the reported event were noted. Additional information has been requested, and we will report accordingly when it becomes available. The full event site name is (b)(6) hospital.
 
Event Description
It was reported that after some tests were performed by a getinge field service engineer (fse), the cs100 intra-aortic balloon pump (iabp) generated error code #50. It was detected that the motor control pcb was defective and needed to be replaced. There was no patient involvement, and no adverse event was reported.
 
Manufacturer Narrative
A company representative has provided clarification on this complaint event and has been updated accordingly. In addition, the getinge fse later determined that the batteries of the iabp were completely discharged during the installation and that the motor controller board was not defective because the iabp worked fine when he attempted to replace the board. The fse tested the iabp for a further 24 hours without replacing the board and verified that it functioned appropriately and the error was not repeated. All calibration, functional and safety tests were performed, and the iabp passed per factory specifications. The iabp was released to the customer for clinical use. Since the motor controller board was not replaced, no failure analysis is necessary.
 
Event Description
It was reported that after some tests were performed during installation of the cs100 intra-aortic balloon pump (iabp) by a getinge field service engineer (fse), the iabp generated error code #50. It was detected that the motor control pcb was possibly defective and needed to be replaced. The clinical engineering technician and responsible physician at the facility was present when this issue occurred. There was no patient involvement, and no adverse event was reported. This is a possible out of box failure.
 
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Brand NameCS100
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 Key8035416
MDR Text Key126222336
Report Number2249723-2018-01915
Device Sequence Number0
Product Code DSP
Reporter Country CodeBR
PMA/PMN Number
K031636
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 11/28/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/02/2018
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberN/A
Device Catalogue Number0998-00-3013-68
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 Received11/06/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/18/2018
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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