Model Number CS100 |
Device Problems
Break (1069); Crack (1135); Structural Problem (2506)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/03/2023 |
Event Type
malfunction
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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.Investigation is ongoing.A1-a6: patient information has not been provided by the user.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 (b)(4).Therefore, this report is being filed as part of agilent's commitment to due diligence reporting.
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Event Description
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The united kingdom customer reported the coverstainer lower front door developed a large crack and had to be removed for safety.The crack appeared at top left corner of the door which caused the door to hang at an angle.The customer continued to use the instrument for a short period of time but the crack gradually got worse so the customer decided to remove the door to be safe.The door and the corner piece were removed on (b)(6) 2023 by unscrewing it from the bottom section of hinge (p/n 991228) and detaching the shock absorbers (p/n 991103).Nothing ran into or damaged the door.The field service engineer (fse) serviced the instrument and noted the plastic corner of the door with mounted hinge block was removed from the rest of the door.The fse replaced the door and 2 gas struts (shock absorbers) to give correct holding ability of the door in the raised position.The instrument is fully operational, within specification, and ready for use.The customer was able to complete testing with another instrument.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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Agilent technologies has initiated a recall in (b)(6) 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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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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