MAUDE Adverse Event Report: GETINGE DISINFECTION AB 91-SERIES; DISINFECTOR, MEDICAL DEVICES

Model Number 9125

Device Problems Mechanical Problem (1384); Component or Accessory Incompatibility (2897); Difficult to Open or Close (2921); Device Handling Problem (3265)

Patient Problem Injury (2348)

Event Date 09/03/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On 9th september, 2019 getinge became aware about incident with 9125 washer- disinfector.As it was stated by the customer, the door belt came off leading to door not closing.The device operator sustained hand injury when tried to manually close cleen side door on the device.There is no information provided if the injury required medical intervention.

Event Description

On 3th september, 2019 getinge became aware about incident with 9125 washer- disinfector.As it was stated by the customer, the door belt came off leading to door not closing.The device operator sustained hand injury when tried to manually close cleen side door on the device.There is no information provided if the injury required medical intervention.

Manufacturer Narrative

When reviewing reportable events for this type of issues we were able to establish that the received incident is the 1st one registered in the getinge complaint handling systems for issues where operator injured his hand while operating the devices¿ door on 91 series device.There was no serious injury sustained, however we decided to report the complaint based on the potential and in abundance of caution.When the event occurred, the device did not meet its specification and it contributed to event.Upon the event occurrence the device was not being used for patient treatment.During the investigation course, we were able to establish that the most likely root cause of the situation occurrence was the air compressor (accessory for the washer disinfector) installation error, which led to disturbance of the door motion and resulted in the belt that operates the door mechanism being loose.When the door belt malfunction occurred, the motorized door stopped working and the customer tried to close it manually instead of via push button, as indicated in the user manual.This eventually has led to the operator¿s hand getting caught by the door and injured.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.The purpose of this submission is to provide a correction of awareness date included in describe event or problem section.This is caused by the typo made by getinge employee by mistake.#description of event or problem: initial describe event or problem: on 9th september, 2019 getinge became aware about incident with 9125 washer- disinfector.As it was stated by the customer, the door belt came off leading to door not closing.The device operator sustained hand injury when tried to manually close cleen side door on the device.There is no information provided if the injury required medical intervention.Corrected describe event or problem: on 3th september, 2019 getinge became aware about incident with 9125 washer- disinfector.As it was stated by the customer, the door belt came off leading to door not closing.The device operator sustained hand injury when tried to manually close cleen side door on the device.There is no information provided if the injury required medical intervention.

Manufacturer Narrative

The issue is still being investigated by manufacturing site.

Event Description

Manufacturer reference number: (b)(4).

Manufacturer Narrative

The issue is being investigated by manufacturing site.

Event Description

Manufacturer reference number: (b)(4).

• Brand Name: 91-SERIES
• Type of Device: DISINFECTOR, MEDICAL DEVICES
• Manufacturer (Section D): GETINGE DISINFECTION AB; ljungadalsgatan 11; vaxjo
• MDR Report Key: 9128688
• MDR Text Key: 162082096
• Report Number: 9616031-2019-00029
• 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,user f
• Remedial Action: Repair
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 9125
• Device Catalogue Number: 9125-002
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other