On 14th december, 2023 getinge became aware of an issue with one of our examination lights ¿ lucea 40.As it was stated the headlight casing was cracked.Photographic evidence confirmed that issue and indicated that due that crack there were 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.
|
The correction of b5 describe event and problem, h3a device evaluated by manufacturer?, h3b device not eval provide code and h3c if other provide code -explain fields deems required.This is based on the internal evaluation.Previous b5 describe event and problem: on 14th december, 2023 getinge became aware of an issue with one of our examination lights lucea 40.As it was stated the headlight casing was cracked.Photographic evidence confirmed that issue and indicated that due that crack there were 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 14th december, 2023 getinge became aware of an issue with one of our examination lights lucea 40.As it was stated the headlight cover was cracked on the mounting screw.Photographic evidence confirmed that issue and indicated that due that crack there were 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.Previous h3a device evaluated by manufacturer?: no.Corrected h3a device evaluated by manufacturer?: yes.Previous h3b device not eval provide code: other.Corrected h3b device not eval provide code: blank.Previous h3c if other provide code -explain: device not returned to manufacturer.Corrected h3c if other provide code -explain: blank.Getinge became aware of an issue with one of our examination lights lucea 40.As it was stated the headlight cover was cracked on the mounting screw.Photographic evidence confirmed that issue and indicated that due that crack there were 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.Based on an information gathered, the device was repaired by replacement of: screw cx m3x8 stainless steel a2 (ard600970308), handle interface with fork - lucea 40 (ard368605998) and transparent plastic cover - lucea 40 (ard368606555).It was established that when the event occurred, the examination light did not meet its specification due to damage of dome cover, resulting in missing particles, 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.A root cause analysis was performed by subject matter experts at manufacturing site.Based on some internal test done by maquet sas (ref: (b)(4) for instance), 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.Tests performed by getinge did not lead to cracks as reported in the complaint at hand.The cracks detected on the handle interface and transparent cover fixing points were probably caused by improper use, collisions, incompatible cleaning products or protocol.To prevent any incident the the lucea10/40 instruction for use ifu 01701 mentions to check the integrity of the light heads during daily inspection and describes how to clean and disinfect the light head.This document includes some recommended products and some prohibited products.In order to avoid mechanical stresses applied on the transparent housing during use the lucea10/40 instruction for use ifu 01701 mentions to handle the light head by the handle ( ifu_lucea_10_40_01701en12_extract, pages 22-25, 30).Getinge shall continue to monitor for any further events of this nature and do not propose any further action at this time.
|
On 14th december, 2023 getinge became aware of an issue with one of our examination lights ¿ lucea 40.As it was stated the headlight cover was cracked on the mounting screw.Photographic evidence confirmed that issue and indicated that due that crack there were 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.
|