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Model Number 8668 |
Device Problem
Fire (1245)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/26/2023 |
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 the manufacturer.
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Event Description
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On (b)(6) 2023, getinge became aware of an issue with the 86-series washer disinfector with the model name: 8668.As it was stated, the customer notified of a fire in the sterile processing department of their outpatient clinic.The equipment that caused the incident was identified, as the device, which is reported herein.Additionally, damage to adjacent equipment was reported.It was confirmed that a fire alarm started at the facility and an evacuation was carried out.We have not been informed about any injuries or delays in life-saving procedures as a result of this event.Getinge has not been allowed to access the facility and inspect the equipment so far.There is no information about any adverse outcome regarding the event, however we have decided to report the issue based on the potential of harm if the issue was to reoccur.
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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 april 30th, 2023, getinge became aware of an issue with the 86-series washer disinfector with the model name: 8668 and the serial number: (b)(6).The unit was manufactured on 18th march, 2013 and installed on (b)(6) 2013 as it was stated, the customer notified of a fire in the sterile processing department of their outpatient clinic.The equipment that caused the incident was identified, as the device, which is reported herein.Unfortunately, further details are unavailable at this time, making it impossible to define the case.It was established that the getinge product was directly involved with the reported event and not meet its specification.Trend review of customer product complaints with the same issue involved on this type of devices reported within the last 5 years was performed but did not provide any signals that triggered further scrutiny.None of the provided information indicates that upon the event occurrence the device was being used for patient treatment or diagnosis.We believe that devices in the market are performing correctly overall.Given the circumstances and the fact that there is no apparent trend in complaints of this nature, we shall continue to monitor for any further events of this nature.
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Search Alerts/Recalls
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