Model Number CM320-4 |
Device Problem
Device Handling Problem (3265)
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Patient Problem
Contusion (1787)
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Event Date 08/14/2019 |
Event Type
malfunction
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Manufacturer Narrative
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The issue is being investigated by manufacturing site.Device not returned to the manufacturer.
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Event Description
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On (b)(6) 2019 getinge became aware of an issue with one of washers disinfectors - cm320.As it was stated, the operator of the device, during its cleaning, pinched his hand between the cleaning rack and the long-loading station program scanning device.The injury was not classified as a serious one, however we decided to report it based on the potential, as the issue could led to serious injury or worse.
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Manufacturer Narrative
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The issue is still being investigated by manufacturing site.
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Event Description
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Manufacturer's reference number (b)(4).
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Event Description
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Manufacturer reference number: (b)(4).
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Manufacturer Narrative
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The issue in being investigated by a manufacturer site.
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Manufacturer Narrative
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When reviewing reportable events for this type of issues we were able to establish that received incident is the first one registered in getinge complaint handling systems regarding the failure investigated (the operator pinched his hand while cleaning the device).With the complaint at hand, there was no indication of a serious injury occurrence, however we decided to report this complaint based on the potential and in abundance of caution.The product involved in the incident is the cm320-4 washer disinfector with the serial number: (b)(6).The unit was manufactured on 19th october, 2016.The information collected to date and as a result of the performed investigation allowed us to establish that the operator pinched his hand while cleaning the item which was done not according to instruction given as part of user manual.In particular, the cleaning activities of racks should not be performed manually but by running the dedicated program via the washer disinfector.Moreover, the automatic process of loading/unloading the rack does not require manual pushing into the device.In addition, the user manual is providing a warning to the customer to be mindful and caution while working on the machine's moving parts.In summary, when the event occurred the device did not fail to meet its specification.The most likely root cause was not related with a technical device malfunction but with an error in user operating procedure.When the event occurred, the device was not being used for treatment or diagnosis of the patient.We currently do not have any information that would warrant further action towards the device manufacturing or devices on the market, however getinge will continue to monitor the customer experiences with the device for any future information.
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Event Description
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Manufacturer reference number: (b)(4).
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Search Alerts/Recalls
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