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Model Number ARD567501970 |
Device Problems
Crack (1135); Detachment of Device or Device Component (2907)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/22/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Additional information will be provided following the conclusion of the investigation.Device not returned to manufacturer.
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Event Description
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On 25th january, 2021 getinge became aware of an issue with one of surgical lights - axcel.As it was stated, during the medical procedure with a patient, while a movement of the headlight was initiated, the connection between a fork and a headlight broke and the headlight fell off.There was no injury reported however we decided to report the issue in abundance of caution as any parts falling off may lead to serious injury or worse.
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Manufacturer Narrative
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Getinge became aware of an issue with one of the surgical lights ¿ axcel.As it was stated, during the medical procedure with a patient, while a movement of the light head was initiated, the connection between a fork and a light head broke and the ligh thead fell off.There was no injury reported however we decided to report the issue in abundance of caution as any parts falling off may lead to serious injury or worse.After the incident occurrence, the device has been put out of usage by the customer and replaced by the different surgical light.It was established that when the event occurred the surgical light did not meet its specification due to detached light head and it contributed to the event.It is unknown if the device was being used for the patient treatment when the issue occurred.The investigation was performed by the subject matter expert from the manufacturing site.The light head structure¿s axle part sheared off and detached from its fork.The detachment of the light head is evaluated to have been caused by to the rupture of the axle part.The structure material, ixef 1022 is a 50% glass-fiber reinforced, general purpose polyarylamide compound that exhibits very high strength and rigidity and excellent creep resistance.The torque and tensile tests performed on the axcel light head comply with the iec standard 60601.An excessive effort concentrated on the light head was evaluated by subject matter experts at the manufacturer to have caused the rupture of the structure at the level of the axle.The user manual 0125104 mentions that the surgical light must be prepositioned prior any procedure to avoid interactions and collision with other devices.This would allow avoid any excessive forces.Given the circumstances and the fact that there is no apparent trend in the complaints we shall continue to monitor for any further events of this nature and do not propose any further action at this time.
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Event Description
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Manufacturer's reference number (b)(4).
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Search Alerts/Recalls
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