Model Number ARD568404901 |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 02/01/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Additional information will be provided following the conclusion of the investigation.Device not returned to manufacturer.
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Event Description
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On (b)(6) 2021 getinge became aware of an issue with single screen holder.The problem was crack of sterilizable handle's ring, leading to missing plastic particle.There was no injury reported however we decided to report the issue in abundance of caution as any parts falling off may cause potential infection.
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Event Description
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Manufacturer's referene number (b)(4).
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Manufacturer Narrative
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The correction of d4 catalog #, model # and serial # deem required.This is based on the information provided from service unit.D4 previous: catalog # 567706902.Model # 567706902.Serial # (b)(6).D4 corrected: catalog # ard568404901.Model # ard568404901.Serial # (b)(6).
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Event Description
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Manufacturer's referene number (b)(4).
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Manufacturer Narrative
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Getinge became aware of an issue with single screen holder.The problem was crack of sterilizable handle's ring, leading to missing plastic particles.There was no injury reported, however, we decided to report the issue in abundance of caution as any parts falling off may cause potential infection.It was established that when the event occurred, the device did not meet its specification as the ring should not crack and particles should not be missing and it contributed to the event.The provided information did not indicate that the device was being used for patient treatment when the event took place.It is likely that this breakage occurred over time because of repetitive shocks.It is visually detectable during the inspection performed by the users before any surgical procedure.This case with a standard single screen holder remains isolated.We believe the related devices are performing correctly in the market.We also believe that if the manufacturer recommendation would have been followed the incident would have been avoided.
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Search Alerts/Recalls
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