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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD LINEAR 7.5FR. 40CC SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE CORP. - FAIRFIELD LINEAR 7.5FR. 40CC SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number 0684-00-0480-01
Device Problems Inflation Problem (1310); Leak/Splash (1354)
Patient Problems Fever (1858); No Consequences Or Impact To Patient (2199)
Event Date 08/25/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(6). The device has not been returned to the manufacturer so we are unable to complete an evaluation. If provided we will send a supplemental report with our additional findings. Complaint record id # (b)(4).
 
Event Description
It was reported that during intra-aortic balloon (iab) therapy on a patient with st-segment elevation myocardial infarction (stemi), the balloon did not fully open. Augmentation of the patient is 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 cs300 intra-aortic balloon pump (iabp). The following three alarms were found, alarm has no trigger, augmentation below limit set and triggers electrocardiogram (ekg). It appears that the patient had a fever, but is unclear if this is related to the alleged product issue. A separate report will be submitted for the cs300 iabp.
 
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Brand NameLINEAR 7.5FR. 40CC
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - FAIRFIELD
15 law drive
fairfield NJ 07004
Manufacturer (Section G)
DATASCOPE CORP. - FAIRFIELD
15 law drive
fairfield NJ 07004
Manufacturer Contact
dorota wolpiuk
15 law drive
fairfield, NJ 07004
MDR Report Key10576534
MDR Text Key208223910
Report Number2248146-2020-00492
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeTH
PMA/PMN Number
K041281
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 Number0684-00-0480-01
Device Catalogue Number0684-00-0475
Device Lot Number3000107635
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
Date Device Manufactured11/01/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/23/2020 Patient Sequence Number: 1
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