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U.S. Department of Health and Human Services

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

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DATASCOPE CORP. CS300 SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number N/A
Device Problems Output below Specifications (3004); Appropriate Term/Code Not Available (3191)
Patient Problem No Patient Involvement (2645)
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 the company standard operating procedure since the device manufacture date is greater than one year from the event date. A getinge field service engineer (fse) evaluated the iabp unit and was able to reproduce the reported issue. The low vacuum alarm was caused by pump heads being reversed. The fse corrected pump head direction and the fault alarm cleared. The unit passes all functional and safety tests except battery run time. The batteries failed the runtime test. The getinge fse was told that the customer will replace batteries if needed on their own. The customer was advised that, getinge does not recommend the use of non-original equipment manufactured (non-oem) parts and cannot guarantee the performance of units making use of non-oem parts. The unit was returned to customer and not cleared for clinical use at this time. The biomedical engineer of the facility later on advised that, the unit was left unplugged and was not fully charged when the fse worked on it. The biomed had been running it the previous day on and off of battery power and had left it plugged into an electrical safety analyzer which was left shut off overnight. The fse was informed of this at the time. After leaving the unit to fully charge, a pm was performed and it passed the battery run time test and pm. The batteries were replaced (b)(6) 2018 and were not bad, the fse tested them when they were depleted. The unit has been returned to service.
 
Event Description
It was reported that during preventative maintenance (pm) performed by the customer's biomed, the cs300 intra-aortic balloon pump (iabp) generated a "low vacuum" and fault code #61. There was no patient involved and no adverse event reported.
 
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Brand NameCS300
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP.
14 philips parkway
montvale NJ 07645
Manufacturer (Section G)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ 07430
Manufacturer Contact
1300 macarthur blvd
mahwah, NJ 07430
MDR Report Key8806823
MDR Text Key151576130
Report Number2249723-2019-01129
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 07/18/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/19/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number0998-00-3023-53
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Event Location No Information
Date Manufacturer Received06/27/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/01/2007
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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