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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AGILENT TECHNOLOGIES SINGAPORE (INTL.) PTE LTD. AUTOSTAINER LINK 48
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AGILENT TECHNOLOGIES SINGAPORE (INTL.) PTE LTD. AUTOSTAINER LINK 48 Back to Search Results
Model Number AS480
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/27/2020
Event Type  malfunction  
Manufacturer Narrative
Root cause: potential alteration of staining in this case was due to improper operation of the probe kit.The problem was solved by field service engineer with repair of the part.Following the repair, the instrument was fully operational within specifications, without errors and available for the user.Failure mode description: following a probe malfunction or if the part stops working; the resulting failure modes could occur.Leak from probe or drip from z-head could impact aspiration/dispense.These failure modes have the potential to alter staining.
 
Event Description
Based on complaint report or investigated failure mode, there was potential for a staining alteration.Customer complaint record reported the event as follows: leaking probe no direct or indirect patient harm or user harm have been reported.
 
Event Description
Based on complaint report or investigated failure mode, there was potential for a staining alteration.Customer complaint record reported the event as follows: leaking probe no direct or indirect patient harm or user harm have been reported.
 
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Brand Name
AUTOSTAINER LINK 48
Type of Device
AUTOSTAINER LINK 48
Manufacturer (Section D)
AGILENT TECHNOLOGIES SINGAPORE (INTL.) PTE LTD.
no.1 yishun avenue 7
singapore north east, 76892 3
SN  768923
MDR Report Key11059777
MDR Text Key223803381
Report Number3003423869-2020-00003
Device Sequence Number1
Product Code KPA
UDI-Device Identifier05700572035497
UDI-Public05700572035497
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Remedial Action Repair
Type of Report Initial,Followup
Report Date 12/22/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/22/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberAS480
Device Catalogue NumberAS48040
Was Device Available for Evaluation? Yes
Date Manufacturer Received11/27/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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