Model Number CS100 |
Device Problems
Break (1069); Structural Problem (2506)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/19/2024 |
Event Type
malfunction
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Event Description
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The australia customer reported the lower door of the coverstainer is broken.A picture was provided which shows the door is detached at the upper left corner of the door.It was cracked at first and is now detached.It was reported the door cracked/broke due to normal operations.This issue did not affect the utility of the instrument and so testing was able to be completed with the same instrument.Diagnostics were not altered.There was no direct or indirect patient harm or user harm reported.The investigation is ongoing, captured in capa01211 and a supplemental will be provided when new pertinent information is received.
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Manufacturer Narrative
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No erroneous staining result was reported by the customer in connection with this incident.No patient or user harm was indicated.A1-a6: patient information has not been provided by the user.E1 (b)(6).While there was no direct, or indirect, user harm reported for this event; it is being reported due to the potential for harm if the event were to reoccur.The instrument experienced a similar failure mode related to reportable complaint with injury, reference number mdr 3003423869-2023-00084, mhra 2023/006/021/601/051, agilent cc-0077837.Therefore, this report is being filed as part of agilent's commitment to due diligence reporting.
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Manufacturer Narrative
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Agilent technologies has initiated a recall in april 2024 with the scope of notifying all coverstainer customers of the following issue: the lower door that opens to the reagent bottles is cracking and/or breaking off in the upper corner of the plexiglass.Capa01211 has addressed the issue and the investigation has been completed.Agilent technologies has determined the root cause as such; the lower door support bracket, which connects the hinges to the lower door, is only attached to the plexiglass and not to the metal frame which is the main support structure of the lower door.The weight of the plexiglass door is in turn cracking/breaking at this joint.Customers have been notified of this issue via a customer letter.Agilent technologies worked with the manufacturer to re-design the support bracket for the lower door hinges, so the weight of the lower door assembly is not supported by the plexiglass, but by the metal frame of the lower door.This new bracket is being verified for effectiveness; once completed this bracket will be installed at the customer's next service visit.
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Event Description
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The australia customer reported the lower door of the coverstainer is broken.A picture was provided which shows the door is detached at the upper left corner of the door.It was cracked at first and is now detached.It was reported the door cracked/broke due to normal operations.This issue did not affect the utility of the instrument and so testing was able to be completed with the same instrument.The field service engineer (fse) serviced the instrument and replaced the lower door which resolved this malfunction.The instrument is fully operational, within specification, and ready for use.Diagnostics were not altered.There was no direct or indirect patient harm or user harm reported.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information that recall reference number, (b)(4), has been received.Agilent technologies recall, reference number (b)(4), has been initiated april 2024 with the scope of notifying all coverstainer customers of the following issue: the lower door that opens to the reagent bottles is cracking and/or breaking off in the upper corner of the plexiglass.Capa01211 has addressed the issue and the investigation has been completed.Agilent technologies has determined the root cause as such; the lower door support bracket, which connects the hinges to the lower door, is only attached to the plexiglass and not to the metal frame which is the main support structure of the lower door.The weight of the plexiglass door is in turn cracking/breaking at this joint.Customers have been notified of this issue via a customer letter.Agilent technologies worked with the manufacturer to re-design the support bracket for the lower door hinges, so the weight of the lower door assembly is not supported by the plexiglass, but by the metal frame of the lower door.This new bracket is being verified for effectiveness; once completed this bracket will be installed at the customer's next service visit.
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Search Alerts/Recalls
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