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U.S. Department of Health and Human Services

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

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DATASCOPE CORP. - MAHWAH CS300 SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number 0998-00-3023-53
Device Problem Connection Problem (2900)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/25/2021
Event Type  malfunction  
Manufacturer Narrative
Testing of actual/suspected device: (10): a getinge field service engineer (fse) was dispatched to evaluate this unit. The fse arrived on site and checked the logs, he was unable to see any issue with the pressures. The fse connected his patient simulator and was able to zero the pressure and measure the pressure within tolerance. In addition, the customer did not have the pressure cable that was used during this issue and the fse was unable to verify if the user's cable has a malfunction. Subsequently, the fse perform all the test and calibrations. Unit passed all calibration, functional and safety tests performed as per manufacture specifications. The iabp was returned to the customer and cleared for clinical use. A supplemental report will be submitted when the investigation is completed.
 
Event Description
It was reported that the cs300 intra-aortic balloon pump (iabp) had a sensor failure with the pressure cable and the unit stopped reading the pressure while providing therapy on a patient. The iabp was switched and the pressure cable functioned correctly. No patient harm, serious injury or adverse event was reported.
 
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Brand NameCS300
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ
Manufacturer (Section G)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ
Manufacturer Contact
dorota wolpiuk
1300 macarthur blvd
mahwah, NJ 
MDR Report Key12332140
MDR Text Key266918706
Report Number2249723-2021-01840
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
PMA/PMN Number
K063525
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/17/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number0998-00-3023-53
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?
Event Location No Information
Date Manufacturer Received07/26/2021
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 08/17/2021 Patient Sequence Number: 1
Treatment
SENSATION 34CC.
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