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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 Problem Device Inoperable (1663)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/12/2017
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.
 
Event Description
The customer reported that while in use on a patient, the intra-aortic balloon pump (iabp) stopped working.The iabp did not turn off, but it stopped working.The customer had no patient details.However, there was no patient injury or adverse event reported.
 
Manufacturer Narrative
07/26/2017 03:05 pm (gmt-4:00) added by (b)(6)(b)(6): the service territory manager (stm) could not duplicate the alleged malfunction.Both the alarm and failure logs were checked and the intra-aortic balloon pump (iabp) was run without any issues.Functionality checks were performed to factory specifications.The iabp was returned back to clinical use upon completion.The stm also replaced the following broken, non-critical parts due to their cosmetic appearance: the iv bracket, the iv shaft fasten and the helium tank valve knob parts.
 
Event Description
The customer reported that while in use on a patient, the intra-aortic balloon pump (iabp) stopped working.The iabp did not turn off, but it stopped working.The customer had no patient details.However, there was no patient injury or adverse event reported.
 
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Brand Name
CS300
Type of Device
SYSTEM, 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 Key6687120
MDR Text Key79248088
Report Number2249723-2017-00050
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 health professional,user faci
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 07/26/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/05/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number0998-00-3023-53
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Device AgeYR
Date Manufacturer Received06/13/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/01/2004
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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