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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 No Display/Image (1183)
Patient Problems Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/12/2021
Event Type  malfunction  
Manufacturer Narrative
Testing of actual/suspected device (10): a getinge field service engineer (fse) was dispatched to investigate. The fse evaluated the iabp unit and cleaned the coiled cable contacts. The display connections were also checked but the fse was unable to duplicate the customer's reported issue. No problems were observed. Subsequently, the fse completed all safety, functionality, and calibration checks and all tests passed to factory specifications. The iabp unit was cleared for clinical use and released to the customer. A supplemental report will be submitted upon completion of our investigation.
 
Event Description
It was reported that during use on a patient, the screen for the cs300 intra- aortic balloon pump (iabp) went blank. It was later reported that the display would go blank but came back on and the iabp unit did not stop assisting. The iabp unit was swapped with another iabp unit but the patient passed away. The customer has not attributed the patient's death to the reported issue. The associated intra-aortic balloon (iab) has been reported under medwatch report # 2248146-2021-00486. Screen stude blank while on patient. Screen stude blank while on patient. Patient passed due to switching equip over. Po: (b)(4) all information given by contact person, (b)(6). (b)(4). Cs300,english,110v,domestic. (b)(4).
 
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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
brian schaeffer
1300 macarthur blvd
mahwah, NJ 
MDR Report Key12276549
MDR Text Key265065391
Report Number2249723-2021-01717
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 Health Professional,User Facility,Company Representative
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup,Followup
Report Date 03/31/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/04/2021
Is this an Adverse Event Report? Yes
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
Date Manufacturer Received03/31/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/14/2010
Is the Device Single Use? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 08/04/2021 Patient Sequence Number: 1
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