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Model Number ARD568601997 |
Device Problems
Fracture (1260); Detachment of Device or Device Component (2907)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/21/2023 |
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 march 28, 2023 getinge became aware of an issue with one of our examination lights lucea 40.As it was stated the headlight cover was broken resulting in missing particles.There was no injury reported, however we decided to report the issue in abundance of caution as any particles falling off during examination may lead to potential infection of the patient.
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Event Description
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On 21st march, 2023 getinge became aware of an issue with one of our examination lights ¿ lucea 40.As it was stated the headlight cover was broken resulting in missing particles.There was no injury reported, however we decided to report the issue in abundance of caution as any particles falling off during examination may lead to potential infection of the patient.
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Manufacturer Narrative
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According to the reporting timeframe we would like to provide the information about current status of the issue.Please be advised that it is being investigated.Additional information will be provided following the conclusion of the investigation.The correction of b3 date of event and b5 describe event and problem deems required.This is based on the internal evaluation.Previous b3 date of event: (b)(6) 2023, corrected b3 date of event: (b)(6) 2023.Previous b5 describe event and problem: on 28th march, 2023 getinge became aware of an issue with one of our examination lights ¿ lucea 40.As it was stated the headlight cover was broken resulting in missing particles.There was no injury reported, however we decided to report the issue in abundance of caution as any particles falling off during examination may lead to potential infection of the patient.Corrected b5 describe event and problem: on (b)(6) 2023 getinge became aware of an issue with one of our examination lights ¿ lucea 40.As it was stated the headlight cover was broken resulting in missing particles.There was no injury reported, however we decided to report the issue in abundance of caution as any particles falling off during examination may lead to potential infection of the patient.
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Manufacturer Narrative
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Getinge became aware of an issue with one of our examination lights ¿ lucea 40.As it was stated the headlight cover was broken resulting in missing particles.Getinge technician also stated that the covers were broken due to the user not using the handle on the light and grabbing the light by the lens.There was no injury reported, however we decided to report the issue in abundance of caution as any particles falling off during examination may lead to potential infection of the patient.According to the information provided by getinge technician, the affected parts (ard368605998 - handle interface with fork - lucea 40, ard368606555 - transparent plastic cover - lucea 40) have been replaced.It was established that when the event occurred, the examination light did not meet its specification due to cracks and missing particles from covers, which contributed to the event.Provided information does not indicate if upon the event occurrence the device was or was not being used for patient treatment.Review of received customer product complaints related to investigated issue, revealed that there were no injuries to a user nor to a patient or operator when this particular malfunction occurred.We can assume that the failure ratio of cracks and missing particles on lucea 10/40 devices is moderate.Malfunction investigated herein was further analysed by subject matter experts at maquet sas.As they stated, based on some internal test done by maquet sas (e.G.Ref: cre 12-085), only abnormal use (violent collisions, excessive pressure¿) or the use of incompatible cleaning products or protocol, can damage this device as reported in this complaint.The user manual explains how to check the light heads during daily inspection.To avoid any similar incident, the lucea product must be used according with the user manual information.We believe the related devices are performing correctly in the market.We also believe that if the manufacturer recommendation had been followed the incident could have been avoided.Getinge 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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