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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 N/A
Device Problems Failure to Sense (1559); Pressure Problem (3012)
Patient Problem Fever (1858)
Event Date 08/25/2020
Event Type  malfunction  
Manufacturer Narrative
Additional information has been requested, and a supplemental report will be submitted when same becomes available.
 
Event Description
It was reported that during cs300 intra-aortic balloon pump (iabp) therapy on a patient with st-segment elevation myocardial infarction (stemi), the intra-aortic balloon catheter (iabc) did not fully open. Augmentation of the patient was not as low as the first day of therapy. The doctor thought the balloon had ruptured. The balloon was removed from the patient. The company representative was notified by the facility of the incident and inquired with the doctor of the fever again. Subsequently, the company representative went to the hospital and printed out the alarm logs on the iabp, and the following three alarms were found, "alarm has no trigger", "augmentation below limit set", "electrocardiogram (ekg) and pressure alarms. " it appears that the patient may have had a fever, but is unclear if this is related to the alleged product issue. A separate report will be submitted for the iabc.
 
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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 07430
Manufacturer (Section G)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ 07430
Manufacturer Contact
dorota wolpiuk
1300 macarthur blvd
mahwah, NJ 07430
MDR Report Key10576527
MDR Text Key208223978
Report Number2249723-2020-01549
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeTH
PMA/PMN Number
K063525
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/23/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number0998-00-3023-XX
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/27/2020
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 09/23/2020 Patient Sequence Number: 1
Treatment
LINEAR 7.5 FR. 40 CC
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