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

Model Number 8666

Device Problem Fluid/Blood Leak (1250)

Patient Problem Unspecified Musculoskeletal problem (4535)

Event Date 06/07/2022

Event Type  malfunction  

Event Description

On (b)(6) 2022 getinge became aware of an issue with one of the washer-disinfectors with the model name: 8666.The event took place on (b)(6) 2022.As it was stated the device had a major leak.The staff laid down absorbent pads on the floor to contain water.A technician walked on the wet area and slipped on saturated pads twisting her back.It has been stated that earlier on the day of event leaks on the device were found, and the issue was solved by replacing all gaskets and tightening all connections.During the getinge technician service of the device on a next day a test cycle was run and no leak was found.Some of the trays that are put into the washer are too long and if not put in properly they stick out past the rack.If tray is not put in the correct way when the door hits the tray while closing and the door does not seal correctly.As a consequence, when the washer circulation pump starts up, water can pass by the seal and flood the floor.However, this scenario was not confirmed, as no leak was found.So far, we have not been informed about any serious injury as a consequence of reported issue, however we decided to report the issue in abundance of caution and based on the potential for serious injury if the situation was to reoccur.

Manufacturer Narrative

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

Manufacturer Narrative

On june 8, 2022, getinge became aware of an incident that took place on (b)(6) 2022 on the 86-series washer-disinfector with the model name: 8666, with the catalog number: s-8666913-ctom and the serial number: (b)(6).The unit was manufactured on may 10, 2006 and installed on december 29, 2006.The reported issue is related to slippage on a wet floor and the resulting injury.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 would warrant further scrutiny.The customer allegation was that the device was leaking.The getinge service technician examined the device and found leaks.The device was repaired, tested for leaks and overall performance and handed back for customer¿s use in working condition.Later that day, the device had another, major leak.The staff put on the floor absorbent pads to contain the water.The technician walked on the wet area and slipped on saturated pads twisting her back.The getinge service technician visited the site on a next day, inspected the device during a test cycle and did not find any leak.It was noticed that some of the trays that are put into the washer are too long and if not put in properly, they stick out past the rack, hitting the door while closing and preventing the door to seal correctly.Consequently, when the washer circulation pump starts up, water passes by the seal and floods the floor.This scenario was not confirmed however, as no leak was detected by the technician.It was confirmed that when the event occurred, the device was directly involved and did not meet its specification.The device was not being used for treatment or diagnosis of the patient.We are not aware if the described issue caused or contributed to the serious injury or worse, however we report the event in abundance of caution and based on the potential that for a serious injury if the situation was to reoccur.We currently do not have any information that would warrant further action towards the device manufacturing or devices on the market, however as per our complaint handling processes will continue to monitor the customer experiences with the device for any future information.

Event Description

Manufacturer's reference number: (b)(4).

• 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: 14673628
• MDR Text Key: 301339563
• Report Number: 9616031-2022-00012
• 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: 06/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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: 06/06/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/10/2006
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1