MAUDE Adverse Event Report: GETINGE DISINFECTION AB 46-SERIES; DISINFECTOR, MEDICAL DEVICES

Model Number 46-4

Device Problem Sharp Edges (4013)

Patient Problem Laceration(s) (1946)

Event Date 01/09/2023

Event Type  Injury  

Event Description

On january 4th, 2023 getinge became aware of an issue with the 46-series washer disinfector.As it was stated the machine was leaking water from the lower right hand corner of the door.The getinge service technician visited customer site on (b)(6) 2023 and inspected the device.No leakage was found, however the door switch issue was noticed.Moreover, the temperature during wash phase was not increasing properly.The solenoid switch was replaced and the door switch was adjusted.The device was tested and returned for use in operational state.Additionally, during cleaning the inner side of the door surface with an alcohol the technician cut his finger on a sharp edge of the door metal part.The edge was knife sharp and cut the body through the towel used for cleaning.The technician needed medical treatment of the deep cut wound in index finger - the wound was glued.The injury has been classified as serious as medical intervention was needed to preclude long term consequences.

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.Device not returned to the manufacturer.

• Brand Name: 46-SERIES
• Type of Device: DISINFECTOR, MEDICAL DEVICES
• Manufacturer (Section D): GETINGE DISINFECTION AB; ljungadalsgatan 11; vaxjo
• Manufacturer (Section G): GETINGE DISINFECTION AB; ljungadalsgatan 11; vaxjo
• Manufacturer Contact: dennis genito ; ljungadalsgatan 11; vaxjo
• MDR Report Key: 16202876
• MDR Text Key: 307659955
• Report Number: 9616031-2023-00002
• Device Sequence Number: 1
• Product Code: MEC
• Combination Product (y/n): N
• Reporter Country Code: FI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 46-4
• Device Catalogue Number: 46-4-402-CTOM
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/09/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/30/2019
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention