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

Model Number CM320-2

Device Problems Leak/Splash (1354); Chemical Problem (2893)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/10/2019

Event Type  malfunction  

Manufacturer Narrative

The issue is being investigating by the manufacturing site.Device not returned to the manufacturing site.

Event Description

On the 10th december, 2019 getinge became aware about an issue with one of the washer-disinfectors: cm320-2.During a troubleshooting at the customer site the technicians turned on the device and was sprayed with the water from the hoses.Device was in the standby motion, but in the worst case scenario the water temperature could have reached about 70 degrees and could caused skin burns.Fortunately neither technician nor customer were injured, nevertheless we decided to report the complaint based on the potential an inaboundance of caution.

Manufacturer Narrative

On the (b)(6) 2019 getinge became aware about customer allegation related to water leak occurrence on cm320-2 washer disinfection.The unit was manufactured on 29th march, 2017 and installed on 12th december, 2017.The information collected to date and as a result of the performed investigation allowed us to establish that the water leak occurred on the device due to the damaged of plastic nipples on the booster water supply valve.During the technician inspection, second device deficiency has been found and was related to the detergent leak from detergent pump, discolorating the cables in the service area.The leak was caused by the damaged part of the detergent pump ¿ o-ring.Fortunately, the investigated event has not resulted in and adverse consequences to the user and was found to be a single and isolated event.In summary, when the event occurred, the getinge device was directly involved and did not meet its¿ specification.Upon the event occurrence the device was not being used for patient treatment.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

Manufacurer reference number (b)(4).

Event Description

Manufacturer reference number (b)(4).

Manufacturer Narrative

The issue is being investigated by the manufacturing site.

Manufacturer Narrative

The issue is being investigated by the manufacturing site.

Event Description

Manufacturer reference number (b)(4).

Manufacturer Narrative

The complaint reported under 9616031-2019-00039 number is considered as related to z-1124-2021 recall.

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: 9480340
• MDR Text Key: 200049476
• Report Number: 9616031-2019-00039
• 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: Replace
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 02/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: CM320-2
• Device Catalogue Number: CM320WD-CTOM
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1124-2021
• Patient Sequence Number: 1