LUCEA ARD568602026

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-26 for LUCEA ARD568602026 manufactured by Maquet Sas.

Event Text Entries

[187254247] Getinge became aware of an issue with one of the lucea 10 light devices. It was reported to us initially that a faulty stopper and welding on the first axe was found, which could consequently lead to detachment from the main tube. There was no injury reported, however we decided to report the issue based on the received indication and in abundance of caution - as a situation in which a suspension arm would actually detach may lead to serious injury. It was established that when the event occurred, the light did not meet its specification as it has been found that breakage of the weld occurred? And this confirms that there was technical deficiency of the device (out of specification) and it contributed to event. In the time when the event occurred the device was not used for patient treatment. During the investigation it was found that in the past the reported scenario has never led to serious injury, nor death. Performed evaluation of returned parts revealed that although the cylinder pin, preventing the tube from falling out, was in its dedicated place however it has been broken in two places, what resulted in its function to be lost. This, in the worst case scenario, could cause the tube being completely uncoupled from the main axis and prevented from falling only by the harness cable. The root cause analysis was performed by the subject matter expert and supported with review of faulty parts received from the market. The conclusion is pointing to misuse being the main cause of pin breakage. When the arm of the device (oriented 90o to the main arm) is moved without loosening the clamping knob to release the pivot as described in the user manual nu_lucea_1001701 page 29 (positioning the light), a strong shearing effect is applied on the cylinder pin. With repetitive motions like this over time, it is probable that the pin can break. We believe that this type of our devices are performing correctly in the market. We also believe that if the manufacturer recommendation as described in the instructions for use and pertaining to avoidance of collisions and checks before use would have been followed the incident could have been avoided.
Patient Sequence No: 1, Text Type: N, H10


[187254248] Getinge became aware of a customer product complaint describing deficiency found during the preventive maintenance activities. The allegation was for a faulty stopper and welding on the first axe. Provided photographic evidence were in line with this description. We were able to confirm that no parts detachment occurred and that the pin was still in place. Our experience shows that in some instances, the pin could be still in place however it could be broken inside the tubing resulting in the function being not fulfill. We were not able to confirm the pin condition, thus we assumed the worst case scenario and possibility that the pin could have been broken inside the tubing. The complaint was therefore decided to be reportable to competent authorities based on the potential and in abundance of caution. Manufacturer's reference number: (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9710055-2020-00051
MDR Report Key9883833
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-26
Date of Report2020-03-26
Date of Event2019-01-11
Date Mfgr Received2020-02-27
Date Added to Maude2020-03-26
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. PASCAL JAY
Manufacturer StreetPARC DE LIMERE AVENUE DE LA POMME DE PIN
Manufacturer CityARDON
Manufacturer CountryUS
Manufacturer G1MAQUET SAS
Manufacturer StreetPARC DE LIMERE AVENUE DE LA POMME DE PIN
Manufacturer CityARDON
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameLUCEA
Generic NameDEVICE, MEDICAL EXAMINATION, AC POWERED
Product CodeKZF
Date Received2020-03-26
Model NumberARD568602026
Device AvailabilityY
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerMAQUET SAS
Manufacturer AddressPARC DE LIMERE AVENUE DE LA POMME DE PIN ARDON US


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-26

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