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

Model Number 8668

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Injury (2348)

Event Type  malfunction  

Manufacturer Narrative

The issue is being investigated by manufacturing site.Device not returned to manufacturer.

Event Description

On (b)(6) 2020 getinge became aware of an issue with wash cart which felling off from the smart trolley (part number: 6020720172, serial number: (b)(4).In described event smart trolley was used with washer disinfector -8666 with serial number (b)(4).Due tue the issue the minor injury was reported.The person from personnel sustained an arm strain when was trying to stop a fully loaded wash cart from falling off from the washer trolley.After described event the person was diagnosed by the onsite medical department and released back to work the following day without limitations.

Manufacturer Narrative

We were able to establish that the issue at hand is the 7th reportable customer product complaint related to issue where cart fell off from the smart trolley, reported within the last 5 years.The smart trolley is used as accessory to the medical device; washer disinfector 8668.The disinfector unit which is used with the affected trolley was manufactured in 2015.None of the provided information indicate that upon the event occurrence the device was being used for patient treatment.During the investigation it was found that in the past the reported scenario has never lead to serious injury or worse, to death.It was established that when the event occurred, the smart trolley which is used with washer disinfector 8668 did not meet its specification.During the investigation course we were able to establish, that the trolley is not working properly, pins fell off from the smart trolley and cart fell onto personnel occurred minor injury.A getinge service technician visited the customer site and inspected the device as part of our investigation, he resolved problems, replaced the required components and the returned trolley for user usage.The cart which fell off from trolley was the single particular failure that was found in this event, which could be a cause of body injury or infection of user of the device.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.The purpose of this submission is also to provide a correction of version or model #.This is based on the result of an internal review noting the initial report was incorrectly submitted stating another manufacture date.#d4 previous version or model #: 8666.Corrected version or model #: 8668.

Event Description

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

Manufacturer Narrative

Issue is being investigated by the manufacturer.

Event Description

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

Event Description

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

Manufacturer Narrative

We were able to establish that the issue at hand is the 7th reportable customer product complaint related to issue where cart fell off from the smart trolley, reported within the last 5 years.The smart trolley is used as accessory to the medical device; washer disinfector 8668.The disinfector unit which is used with the affected trolley was manufactured in 2015.None of the provided information indicate that upon the event occurrence the device was being used for patient treatment.During the investigation it was found that in the past the reported scenario has never lead to serious injury or worse, to death.It was established that when the event occurred, the smart trolley which is used with washer disinfector 8668 did not meet its specification.During the investigation course we were able to establish, that the trolley is not working properly, pins fell off from the smart trolley and cart fell onto personnel occurred minor injury.A getinge service technician visited the customer site and inspected the device as part of our investigation, he resolved problems, replaced the required components and the returned trolley for user usage.The cart which fell off from trolley was the single particular failure that was found in this event, which could be a cause of body injury or infection of user of the device.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.Corrected #h10 additional manufacturer narrative when reviewing reportable events for this type of issues we were able to establish that the complaint is one of several reported with an allegation that the cart fell off from the smart trolley within last 5 years.The smart trolley is used as accessory to the medical device; washer disinfector 8668.The disinfector unit which is used with the affected trolley was manufactured in 2015.None of the provided information indicate that upon the event occurrence the device was being used for patient treatment.During the investigation it was found that in the past the reported scenario has lead to serious injury.It was established that when the event occurred, the smart trolley which is used with washer disinfector 8668 did not meet its specification.During the investigation course we were able to establish, that the trolley is not working properly, pins fell off from the smart trolley and cart fell onto personnel occurred minor injury.A getinge service technician visited the customer site and inspected the device as part of our investigation, he resolved problems, replaced the required components and the returned trolley for user usage.The cart which fell off from trolley was the single particular failure that was found in this event, which could be a cause of body injury or infection of user of the device.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: 10178329
• MDR Text Key: 198701803
• Report Number: 9616031-2020-00022
• 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: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/18/2020

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 Model Number: 8668
• Device Catalogue Number: S-8666913-CTOM
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/05/2020
• Initial Date FDA Received: 06/22/2020
• Supplement Dates Manufacturer Received: 07/15/2020; 08/17/2020; 09/09/2022
• Supplement Dates FDA Received: 08/07/2020; 08/18/2020; 09/12/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/10/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other