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

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).

• Brand Name: CM320-SERIES
• Type of Device: DISINFECTOR, MEDICAL DEVICES
• Manufacturer (Section D): GETINGE DISINFECTION AB; ljungadalsgatan 11; vaxjo
• MDR Report Key: 8909958
• MDR Text Key: 155074556
• Report Number: 9616031-2019-00023
• Device Sequence Number: 1
• Product Code: MEC
• Combination Product (y/n): N
• Number of Events Reported: 1
• 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 Number: CM320-4
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/14/2019
• Initial Date FDA Received: 08/20/2019
• Supplement Dates Manufacturer Received: 08/14/2019; 08/14/2019; 11/05/2019
• Supplement Dates FDA Received: 09/13/2019; 10/11/2019; 11/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other