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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GETINGE DISINFECTION AB CM320-SERIES; DISINFECTOR, MEDICAL DEVICES

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GETINGE DISINFECTION AB CM320-SERIES; DISINFECTOR, MEDICAL DEVICES Back to Search Results
Model Number CM320-4
Device Problem Device Handling Problem (3265)
Patient Problem Contusion (1787)
Event Date 08/14/2019
Event Type  malfunction  
Manufacturer Narrative
The issue is being investigated by manufacturing site.Device not returned to the manufacturer.
 
Event Description
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.
 
Manufacturer Narrative
The issue is still being investigated by manufacturing site.
 
Event Description
Manufacturer's reference number (b)(4).
 
Event Description
Manufacturer reference number: (b)(4).
 
Manufacturer Narrative
The issue in being investigated by a manufacturer site.
 
Manufacturer Narrative
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.
 
Event Description
Manufacturer reference number: (b)(4).
 
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Brand Name
CM320-SERIES
Type of Device
DISINFECTOR, MEDICAL DEVICES
Manufacturer (Section D)
GETINGE DISINFECTION AB
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MDR Report Key8909958
MDR Text Key155074556
Report Number9616031-2019-00023
Device Sequence Number1
Product Code MEC
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Remedial Action Inspection
Type of Report Initial,Followup,Followup,Followup
Report Date 11/06/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberCM320-4
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 08/14/2019
Initial Date FDA Received08/20/2019
Supplement Dates Manufacturer Received08/14/2019
08/14/2019
11/05/2019
Supplement Dates FDA Received09/13/2019
10/11/2019
11/06/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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