Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - FREMONT (CE) ILAB ULTRASOUND IMAGING SYSTEM; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
  • 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
 

BOSTON SCIENTIFIC - FREMONT (CE) ILAB ULTRASOUND IMAGING SYSTEM; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC Back to Search Results
Model Number H749ILAB100C270
Device Problem Retraction Problem (1536)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that automatic pullback failure occurred.An ilab ultrasound imaging system was used in conjunction with an opticross¿ imaging catheter and pullback sled to view the target lesion.During the procedure, an error appeared on the live screen.No patient complications were reported.
 
Event Description
It was reported that automatic pullback failure occurred.An ilab ultrasound imaging system was used in conjunction with an opticross¿ imaging catheter and pullback sled to view the target lesion.During the procedure, an error appeared on the live screen.No patient complications were reported.
 
Manufacturer Narrative
Device evaluated by mfr., eval summary attached, method codes, result codes, conclusion codes updated.Device evaluated by manufacturer:the product was received in good condition with no visible damage observed.Acqpc was installed into a gold standard system and tested for functionality per ilab final system feature test.The system meets specifications of the ilab system functional feature test.There is no known device interaction that could have contributed to the reported failure.The investigation conclusion is not confirmed - returned as there was no evidence of either the alleged issue(s) or any defect which could have contributed to the event.Bsc id:(b)(4).Tw:(b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ILAB ULTRASOUND IMAGING SYSTEM
Type of Device
SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
Manufacturer (Section D)
BOSTON SCIENTIFIC - FREMONT (CE)
47215 lakeview blvd
north dock
fremont CA 94538
MDR Report Key7751744
MDR Text Key116067232
Report Number2134265-2018-06947
Device Sequence Number1
Product Code IYO
Combination Product (y/n)N
PMA/PMN Number
SIMILAR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 07/12/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/06/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberH749ILAB100C270
Device Catalogue NumberILAB100C27
Device Lot Number0000008456
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/19/2018
Date Manufacturer Received09/18/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-