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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 Failure to Run on Battery (1466); Power Problem (3010)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/18/2020
Event Type  malfunction  
Manufacturer Narrative
The production device history record (dhr) for this intra-aortic balloon pump (iabp) was not required to be reviewed as per company standard operating procedure since the device manufacture date is greater than one year from the event date. At this time, the customer has not requested getinge to evaluate the iabp. Additional information is being requested from the customer with regard to the repair and status of the iabp. A supplemental report will be submitted if this information is provided to us.
 
Event Description
It was reported by customer that during use on a patient, the cardiosave intra-aortic balloon pump (iabp) was working properly but remained in battery mode despite trying different outlets and clicking it in and out of the cart multiple times. After discussion with the clinician, the customer was advised swapping out the pump which the customer did. In addition, customer was recommended to take the pump out of service and have biomed look at it. There was no harm or injury to the patient and no adverse event was reported.
 
Manufacturer Narrative
A getinge field service engineer (fse) evaluated the iabp unit and was able to reproduce the reported issue. To fix the issue, the fse replaced the power supply, and performed a full preventive maintenance (pm) with all calibration, functional and safety checks to meet factory specifications. Unit passed all calibration, functional and safety test per factory specifications. The iabp was then released to the customer and cleared for clinical service.
 
Event Description
It was reported by customer that during use on a patient, the cardiosave intra-aortic balloon pump (iabp) was working properly but remained in battery mode despite trying different outlets and clicking it in and out of the cart multiple times. After discussion with the clinician, the customer was advised swapping out the pump which the customer did. In addition, customer was recommended to take the pump out of service and have biomed look at it. There was no harm or injury to the patient 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 Key10258288
MDR Text Key198489644
Report Number2249723-2020-01055
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,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 08/13/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/10/2020
Is this an Adverse Event Report? No
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? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/12/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/01/2016
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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