Model Number ARD567910968 |
Device Problems
Grounding Malfunction (1271); Peeled/Delaminated (1454)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Type
malfunction
|
Manufacturer Narrative
|
Additional information will be provided following the conclusion of the investigation.
|
|
Event Description
|
On (b)(6) 2020 getinge became aware of an issue with the one of our surgical lights.During inspection it was revealed that there was lack of grounding.There was no injury reported however we decided to report the issue based on the potential as lack of grounding is creating risk of electrical shock for operator of the device.
|
|
Event Description
|
On 19th of january 2021 getinge became aware of an issue with the one of our surgical lights - hled.During inspection it was revealed that there was lack of grounding and paint chipping occurred.There was no injury reported however we decided to report the issue based on the potential as lack of grounding is creating risk of electrical shock for operator of the device and paint particles falling into sterile field are creating risk of contamination.
|
|
Manufacturer Narrative
|
Additional information will be provided following the conclusion of the investigation.The purpose of this submission is also to provide a correction of b5: describe event or problem and d1: brand name sections.This is based on the information provided by the service unit.#b5: previous describe event or problem: on 19th of january 2021 getinge became aware of an issue with the one of our surgical lights.During inspection it was revealed that there was lack of grounding.There was no injury reported however we decided to report the issue based on the potential as lack of grounding is creating risk of electrical shock for operator of the device.Corrected additional manufacturer narrative/corrected data: on 19th of january 2021 getinge became aware of an issue with the one of our surgical lights - hled.During inspection it was revealed that there was lack of grounding and paint chipping occurred.There was no injury reported however we decided to report the issue based on the potential as lack of grounding is creating risk of electrical shock for operator of the device and paint particles falling into sterile field are creating risk of contamination.#d1: previous brand name: surgical light corrected brand name: hled.
|
|
Manufacturer Narrative
|
Additional information will be provided following the conclusion of the investigation.The purpose of this submission is solely to provide a correction of b5: describe event or problem and g4: date received by manufacturer sections provided in the initial report.This is based on the invofrmation provided by the service unit.#b5: previous describe event or problem: on 19th of january 2020 getinge became aware of an issue with the one of our surgical lights.During inspection it was revealed that there was lack of grounding.There was no injury reported however we decided to report the issue based on the potential as lack of grounding is creating risk of electrical shock for operator of the device.Corrected additional manufacturer narrative/corrected data: on 19th of january 2021 getinge became aware of an issue with the one of our surgical lights.During inspection it was revealed that there was lack of grounding.There was no injury reported however we decided to report the issue based on the potential as lack of grounding is creating risk of electrical shock for operator of the device.#g4: previous date received by manufacturer: 2020-01-19.Corrected date received by manufacturer: 2021-01-19.
|
|
Event Description
|
On 19th of january 2021 getinge became aware of an issue with the one of our surgical lights.During inspection it was revealed that there was lack of grounding.There was no injury reported however we decided to report the issue based on the potential as lack of grounding is creating risk of electrical shock for operator of the device.
|
|
Event Description
|
Manufacturer's reference number (b)(4).
|
|
Manufacturer Narrative
|
On 19th of january 2021 getinge became aware of an issue with the one of our surgical lights - hled.During inspection it was revealed that there was lack of grounding and paint chipping occurred.There was no injury reported however we decided to report the issue based on the potential as lack of grounding is creating risk of electrical shock for operator of the device and paint particles falling into sterile field are creating risk of contamination.It was established that when the event occurred, the surgical light did not meet its specification as lack of grounding and paint peeling occurred and it contributed to event.None of the provided information indicate that upon the event occurrence the device was being used for patient treatment.During the investigation it was found that in the past the reported scenario has never lead to serious injury or worse, to death.All maquet sas products comply with: ¿ iec 60601-1 ed.2.0 & ed.3.0 general requirements for basic safety and essential performance.¿ iec 60601-2-41 particular requirements for the safety of surgical luminaires and luminaire for diagnosis.¿ paint definition pfc066.This procedure defines maquet sas¿s requirements for all painted parts.¿ disinfection products test: the aim of these tests is to detect any incompatibility with disinfectant.The paint chip or paint damages are due to: impacts, collisions (abnormal use).The lack of earth connections observed for some installed hled configurations is clearly a noncompliance with recommendations and warnings mentioned in our installation manuals.The installation was not carried out by getinge.The customer was communicated with, regarding the fact the installation is what caused the issue.We believe that all remaining devices are performing correctly in the market.Given the circumstances we shall continue to monitor for any further events of this nature and do not propose any further action at this time.
|
|
Search Alerts/Recalls
|