MAUDE Adverse Event Report: AGILENT TECHNOLOGIES SINGAPORE (INTL.) PTE LTD. AUTOSTAINER LINK 48

Model Number AS480

Device Problem Fire (1245)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/30/2019

Event Type  malfunction  

Manufacturer Narrative

Root cause: the zebra printer fire was reported to be localized at the psu.A recall of zebra printer psu was initiated by the manufacturer in 2016, https://www.Zebra.Com/us/en/power-supply-recall.Html (notification of recall was provided to the user /lab by agilent technologies via email).In the event additional information is obtained, this information will be provided via a supplemental report.Failure mode description: the voluntary product recall impacts the psu manufactured by fortron /source, spi, powertech systems (fsp ) group between october 1, 2010 - december 2011 and were either sold as after-market kits or included with the sale of certain models of zebra printers.As a supplier for the product, this report is being filed as part of agilent's commitment to due diligence reporting.

Event Description

Based on complaint report, a third-party manufacturers power supply unit (psu) connected to a zebra printer demonstrated the potential to cause user harm.Customer complaint record reported the event as follows:zebra printer power brick caught on fire and melted power cable and back of the printer.The extent of damage was limited to a melted power cable and plastic at the rear of the printer where the cables connect.The flames were put out quickly with a fire extinguisher.There was no further damage, no injuries to lab personnel, and there no evacuations.

• 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 7; singapore north east, 76892 3; SN 768923
• Manufacturer Contact: sonia siddique ; 1834 tx-71 w; cedar creek, TX 78612 ; 5123328112
• MDR Report Key: 11232539
• MDR Text Key: 228782876
• Report Number: 3003423869-2021-00091
• Device Sequence Number: 1
• Product Code: KPA
• UDI-Device Identifier: 05700572035497
• UDI-Public: 05700572035497
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 01/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AS480
• Device Catalogue Number: AS48030
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/30/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1