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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD LINEAR 7.5 FR. 34CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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DATASCOPE CORP. - FAIRFIELD LINEAR 7.5 FR. 34CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0684-00-0474
Device Problems Leak/Splash (1354); Difficult to Remove (1528)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/02/2023
Event Type  malfunction  
Event Description
It was reported that after 63 hours of intra-aortic balloon (iab) therapy, blood particles were seen inside the iab.It was also noted that blood had entered the pump.The iab was then removed, though, this issue caused difficulty with removal.There was no patient harm or adverse event reported.
 
Manufacturer Narrative
Event site telephone: (b)(6) event site postal code: 560052 additional email address: (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 after 63 hours of intra-aortic balloon (iab) therapy, blood particles were seen inside the iab.It was also noted that blood had entered the pump.The iab was then removed, though, this issue caused difficulty with removal.There was no patient harm or adverse event reported.This report is for the iab involved in this event.A separate report has been submitted for the cs100 intra-aortic balloon pump (iabp) under mfg report number 2249723-2023-04768.
 
Manufacturer Narrative
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
N/a.
 
Manufacturer Narrative
The device has not been returned to the manufacturer so we are unable to complete an evaluation.Reference complaint # (b)(4).
 
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Brand Name
LINEAR 7.5 FR. 34CC 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 Key18039768
MDR Text Key327476666
Report Number2248146-2023-00645
Device Sequence Number1
Product Code DSP
UDI-Device Identifier10607567109695
UDI-Public10607567109695
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 Physician
Type of Report Initial,Followup,Followup
Report Date 11/28/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/31/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number0684-00-0474
Device Lot Number3000296535
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/28/2023
Was Device Evaluated by Manufacturer? No
Date Device Manufactured02/09/2023
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Treatment
CS100 / (B)(6).; UNKNOWN.
Patient Age37 YR
Patient SexFemale
Patient Weight50 KG
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