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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
Catalog Number 0998-00-3023-53
Device Problems Failure to Sense (1559); Failure to Calibrate (2440)
Patient Problem No Patient Involvement (2645)
Event Date 08/13/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The production device history record (dhr) for this intra-aortic balloon pump (iabp) was not required to be reviewed per the company standard operating procedure since the device manufacture date is greater than one year from the event date. The service territory manager (stm) tested the fiber optic module and it passed to specifications. The stm could not duplicate the alleged malfunction. However, the fault logs show "no trigger" and "no pressure trigger" alarms occurred on the reported event date. The iabp passed all functional and safety tests per factory specifications, returned to the customer and cleared for clinical use.
 
Event Description
The customer stated that the cs300 intra aortic balloon pump (iabp) is not sensing / calibrating ap cable. The circumstances under which the event occurred were not reported however no patient involvement or adverse event were 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 Key6835050
MDR Text Key84646817
Report Number2249723-2017-00411
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K063525
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 08/31/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/31/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number0998-00-3023-53
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 Received08/14/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/01/2004
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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