• Decrease font size
  • Return font size to normal
  • Increase font size
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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

DATASCOPE CORP. - FAIRFIELD LINEAR 7.5 FR. 40CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0684-00-0475
Device Problems Filling Problem (1233); Leak/Splash (1354); Difficult to Remove (1528)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/14/2019
Event Type  malfunction  
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. (b)(4).
 
Event Description
It was reported that during intra-aortic balloon (iab) therapy, the balloon had ruptured and blood was seen inside the balloon. The iab was in use nearly 12 hours before it was removed. After the balloon was removed, the doctor observed that the blood inside the balloon had crystallized. There was also an autofill failure alarm generated on the console. There was no reported injury to the patient.
 
Event Description
It was reported that during intra-aortic balloon (iab) therapy, the balloon had ruptured and blood was seen inside the balloon. The iab was in use nearly 12 hours before it was removed. After the balloon was removed, the doctor observed that the blood inside the balloon had crystallized. There was also an autofill failure alarm generated on the console. There was no reported injury to the patient.
 
Manufacturer Narrative
The product has been returned to the manufacturer, but is pending investigation. Once the investigation is completed a supplemental report with our findings will be submitted. (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameLINEAR 7.5 FR. 40CC IAB
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - FAIRFIELD
15 law drive
fairfield NJ 07004
MDR Report Key8583762
MDR Text Key144713287
Report Number2248146-2019-00409
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
PMA/PMN Number
K041281
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 06/11/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/06/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/10/2021
Device Catalogue Number0684-00-0475
Device Lot Number3000077104
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/17/2019
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/17/2019
Is This a Reprocessed and Reused Single-Use Device? No

-
-