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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 Appropriate Term/Code Not Available (3191)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/16/2021
Event Type  malfunction  
Manufacturer Narrative
Root cause: potential alteration of staining in this case was due to improper operation of the dispense check valve.The problem was solved by field service engineer with replacement of the part.Following the replacement, the instrument was fully operational within specifications, without errors and available for the user.Failure mode description: following a dispense check valve malfunction or if the part stops working; the resulting failure modes described could occur: small leakage which could result in drops of buffer through the probe after probe wash, and dispensing failure of the valve.Failure mode in all scenarios has the potential to cause either inconsistent staining, weak staining, or complete absence of staining on some slides.
 
Event Description
Customer complaint record reported the event as follows: probe leakage.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
Manufacturer (Section G)
AGILENT TECHNOLOGIES SINGAPORE (INTL.) PTE LTD.
no.1 yishun avenue
singapore north east, 76892 3
SN   768923
Manufacturer Contact
sonia siddique
1834 state highway 71 west
cedar creek, TX 78612
5123328112
MDR Report Key11667769
MDR Text Key249958081
Report Number3003423869-2021-00189
Device Sequence Number1
Product Code KPA
UDI-Device Identifier05700572035497
UDI-Public05700572035497
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Remedial Action Replace
Type of Report Initial
Report Date 04/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/14/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberAS480
Device Catalogue NumberAS48030
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/16/2021
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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