Model Number ARD569422513A |
Device Problem
Peeled/Delaminated (1454)
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Patient Problem
No Patient Involvement (2645)
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Event Date 09/23/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Additional information will be provided upon results of investigation.
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Event Description
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On (b)(6) 2020 getinge became aware of an issue with one of our surgical light ¿ powerled.The customer alleged about light module which was intermittently staying on.Photographic evidence provided for this issue also reveal a layer of keypad that was peeling off.No information about any injury has been provided however we decided to report this case in abundance of caution as any parts peeling from the device could be a source of contamination.(b)(4).
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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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Additional information will be provided upon results of investigation.
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Manufacturer Narrative
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Getinge became aware of an issue with one of our surgical light ¿ powerled.The customer alleged about light module, which was intermittently staying on.Photographic evidence provided for this issue also reveal a layer of keypad that was peeling off.No information about any injury has been provided however, we decided to report this case in abundance of caution as any parts peeling from the device could be a source of contamination.It was established that when the event occurred, the surgical light did not meet its specification as the keypad tape should not peel off and it contributed to incident.There is no information if at the time when the event occurred the device was or was not being used for patient treatment.The keypad peeling off is a normal wear at this location.In the chapter daily inspections before use, the user manual mentions to check that the keypad is in good condition.As soon as a default is noticed on the keypad tape, its replacement must be performed.The tape is available as spare part.We believe that if the manufacturer recommendation would have been followed the incident would have been avoided.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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