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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 Calibrate (2440); Device Displays Incorrect Message (2591)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/26/2017
Event Type  malfunction  
Manufacturer Narrative
The production device history record (dhr) for this intra-aortic balloon pump (iabp) is not required to be reviewed per company 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 and reported that during initial testing he observed maintenance required code #3. The fse observed atmospheric and shuttle transducers were out of calibration, and could not recalibrate the transducers. The fse isolated the issue to a defective front end board. The fse installed a new front end board and fully calibrated it to specifications. This corrected the atmospheric and shuttle calibration failure. The fse completed the preventive maintenance with full calibration, functional testing and safety check to factory specifications. The iabp passed all functional and safety tests per factory specifications and was returned to customer, cleared for clinical use. (b)(6).
 
Event Description
A getinge field service engineer (fse) reported that during preventive maintenance (pm) he observed a maintenance required code #3. The fse also observed the atmospheric and shuttle transducers were out of calibration and he could not adjust them. The fse has isolated the failure to the front end board. The fse has ordered the parts to address the failure.
 
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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 Key6795481
MDR Text Key82891347
Report Number2249723-2017-00283
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
Reporter Occupation
Type of Report Initial
Report Date 08/15/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/15/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
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 Received07/26/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/01/2007
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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