MAUDE Adverse Event Report: GETINGE DISINFECTION AB 86-SERIES; DISINFECTOR, MEDICAL DEVICES

Model Number 8666

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/21/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On (b)(6), 2022 getinge became aware of an issue related to one of the washer disinfector with the model name 8666.As it was stated, the unit was leaking and due to this fact, the employee slipped on the wet floor and fell.It was stated that the house plumber has been on site after the problem occurred and did some work on the unit.During the inspection, a getinge technician ran several cycles on the washer disinfector and no leak was detected.Nevertheless, we decided to report the complaint in abundance of caution as we cannot confirm that similar event would not contributed to the serious injury if recur.

Event Description

Manufacturer reference number: (b)(4).

Manufacturer Narrative

On 21st october, 2022 getinge became aware of an issue with one of our washer disinfector 86-series washer disinfector with the model name: 8666.The washer disinfector has serial number (b)(6), catalog number s-8666913-ctom and was manufactured on 12th november, 2015.In the alleged event, the person slipped on the wet floor due to the water leakage.It was stated that the house plumber has been on site after the problem occurred and did some work on the unit.Nevertheless, we were not able to confirm what exactly was done.During the inspection, a getinge technician ran several cycles on the washer disinfector and no leak was detected.Nevertheless, we decided to report the complaint in abundance of caution as we cannot confirm that similar event would not contribute to the serious injury if reoccur.After the technician visit it was provided that no issue has been found on the device.A root cause analysis was performed by subject matter expert, however, the customer allegation could not be confirmed as no evidence of leakage was found on the device and the alleged issue could not be recreated.Therefore, the root cause cannot be confirmed.Trend review of customer product complaints with the same issue involved on this type of devices reported within the last 5 years was performed but did not provide any signals that triggered further scrutiny.It was established that the getinge product was directly involved with the reported event.Nevertheless, we could not confirm that the washer disinfector failed to meet its specifications as a reported malfunction was not observed during the visit.None of the provided information indicates that upon the event occurrence the device was being used for patient treatment or diagnosis.We believe that devices in the market are performing correctly overall.Given the circumstances and the fact that there is no apparent trend in complaints of this nature, we shall continue to monitor for any further events of this nature.

• Brand Name: 86-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: 15743058
• MDR Text Key: 303155231
• Report Number: 9616031-2022-00025
• Device Sequence Number: 1
• Product Code: MEC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: 8666
• Device Catalogue Number: S-8666913-CTOM
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/26/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/12/2015
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1