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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE MAHWAH CS300 SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE MAHWAH CS300 SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number N/A
Device Problems Low Battery (2584); Device Displays Incorrect Message (2591)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/07/2018
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. The full name of the initial reported listed is (b)(6). A getinge field service engineer (fse) was dispatched to investigate. The fse evaluated the iabp unit, tested the battery and confirmed that the battery life was low, shorter than expected. The fse replaced the rechargeable batteries, expired safety disk and 2500 hour maintenance kit was installed. Function and calibration were checked, and the iabp performed according to protocol. The iabp was returned to the customer and cleared for clinical.
 
Event Description
It was reported that during patient transport, the cs300 intra-aortic balloon pump (iabp) alarmed "low battery" after only a few minutes. However, the iabp continued to support the patient after the transport was completed and therapy continued. No patient harm or adverse event was reported.
 
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Brand NameCS300
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 Key7479610
MDR Text Key107317562
Report Number2249723-2018-00738
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K063525
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 05/01/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/02/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number0998-00-3023-61
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Device AgeYR
Event Location No Information
Date Manufacturer Received04/10/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/01/2009
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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