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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 Leak/Splash (1354); Failure to Calibrate (2440)
Patient Problem No Patient Involvement (2645)
Event Date 08/22/2017
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 getinge standard operating procedure since the device manufacture date is greater than one year from the event date. A getinge field service engineer (fse) was dispatched to evaluate the unit. The fse removed the compressor and re-seated all gaskets and hoses. The fse ensured all hoses and fitting were correctly seated, screws were tightened to 25 in lbs. And ensured correct vacuum had returned to pump. The fse performed a full calibration and functional test and iabp was returned to customer and cleared for clinical use.
 
Event Description
The customer's biomedical engineer reported that while performing preventative maintenance (pm) on the compressor of the cs300 intra-aortic balloon pump (iabp), he observed a leak in the system and was unable to calibrate the iabp unit. The biomed requested a repair quote. There was no patient involvement, thus no 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 Key6862382
MDR Text Key86306509
Report Number2249723-2017-00474
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 Biomedical Engineer
Type of Report Initial
Report Date 09/12/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/13/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number0998-00-3023-53
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Device AgeYR
Event Location No Information
Date Manufacturer Received08/23/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/01/2007
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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