Model Number 567910968 |
Device Problem
Grounding Malfunction (1271)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Type
malfunction
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Manufacturer Narrative
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Additional information will be provided following the conclusion of the investigation.
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Event Description
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On (b)(6) 2021 getinge became aware of an issue with one of surgical lights.Inspection performed by the getinge technician revealed lack of grounding on the device.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.
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Manufacturer Narrative
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Additional information will be provided following the conclusion of the investigation.The correction of d1 brand name deems required.This is based on the information provided from the service unit.Previous d1 brand name: surgical light.Corrected d1 brand name: hled.
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Event Description
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Manufacturer's reference number: (b)(4).
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Manufacturer Narrative
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On 27th january, 2021 getinge became aware of an issue with one of surgical lights.Inspection performed by the getinge technician revealed lack of grounding on the device.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.It was established that when the event occurred, the surgical light did not meet its specification as lack of grounding 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.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.
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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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