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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
Model Number N/A
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Nausea (1970); Tachycardia (2095)
Event Date 08/02/2018
Event Type  Injury  
Manufacturer Narrative
The production device history record (dhr) for this intra-aortic balloon pump (iabp) was reviewed and no non-conformances related to the reported event were noted. Getinge service was not requested in connection with this event, and the customer has not alleged a malfunction of the iabp.
 
Event Description
It was reported that during cs300 intra-aortic balloon pump therapy, the sensation intra-aortic balloon catheter (iabc) inflation indicator on screen was not fully filling, and patient became nauseous and heart rate rose to150 bpm. The getinge representative explained to the customer that this was only a motion indicator and not an accurate indicator of the extent of inflation. With this being said, the representative did explain that the iabp worked within the confines of one cardiac cycle and; therefore, with the high heart rate the pump could not be as effective. Patient began coding at this time and the physician came in. The representative called back to obtain more information, and patient was revived, but coded again. At the end of the call, the patient was semi-stable, but with poor prognosis. The customer indicated that the patient's status is not product related, but rather due to medical history of myocardial infarctions with stents. The customer was instructed to call back with any further pump issues. A separate report has been submitted on the iabc under medwatch #2248146-2018-00508.
 
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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 Key7818877
MDR Text Key118308588
Report Number2249723-2018-01477
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
Type of Report Initial
Report Date 08/23/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/27/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Device Catalogue Number0998-00-3023-53
Device Lot NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Device Age YR
Event Location No Information
Date Manufacturer Received08/02/2018
Was Device Evaluated by Manufacturer? No
Date Device Manufactured06/28/2001
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: 08/27/2018 Patient Sequence Number: 1
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