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U.S. Department of Health and Human Services

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

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DATASCOPE CORP. - FAIRFIELD LINEAR 7.5 FR. 40CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number 0684-00-0480-07
Device Problems Material Deformation (2976); Pressure Problem (3012)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 10/28/2022
Event Type  Death  
Manufacturer Narrative
Event site postal code - (b)(6).Complete initial reporter name - (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, the augmentation pressure displayed on the cardiosave intra-aortic balloon pump (iabp) was abnormal.The customer observed inaccurate pressure reading which resulted to less augmentation.It was explained that the issue was suspected to be due to a bad pressure transducer, blockage in inner lumen, and a kink in iab.The customer reported that the patient expired.This report is for the iab.A separate report for the cardiosave iabp has been submitted under mfg report number - 2249723-2022-02862.
 
Manufacturer Narrative
The device has not been returned to the manufacturer so we are unable to complete an evaluation.Reference complaint #(b)(4).
 
Event Description
N/a.
 
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Brand Name
LINEAR 7.5 FR. 40CC IAB
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - FAIRFIELD
15 law drive
fairfield NJ
Manufacturer (Section G)
DATASCOPE CORP. - FAIRFIELD
15 law drive
fairfield NJ
Manufacturer Contact
brian schaeffer
15 law drive
fairfield, NJ 
MDR Report Key15813806
MDR Text Key303798541
Report Number2248146-2022-00893
Device Sequence Number1
Product Code DSP
UDI-Device Identifier10607567109718
UDI-Public10607567109718
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
K041281
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 04/10/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/23/2024
Device Model Number0684-00-0480-07
Device Catalogue Number0684-00-0475
Device Lot Number3000152673
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/29/2022
Initial Date FDA Received11/17/2022
Supplement Dates Manufacturer Received04/10/2023
Supplement Dates FDA Received04/10/2023
Was Device Evaluated by Manufacturer? No
Date Device Manufactured02/23/2021
Is the Device Single Use? Yes
Type of Device Usage A
Patient Sequence Number1
Treatment
CARDIOSAVE / (B)(6).
Patient Outcome(s) Death;
Patient Age37 YR
Patient SexMale
Patient Weight88 KG
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