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

Model Number 9125E

Device Problem Fracture (1260)

Patient Problems Fall (1848); Insufficient Information (4580)

Event Date 05/18/2021

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.

Event Description

On (b)(6) 2021 getinge became aware of an issue related to one of the washer-disinfectors, 9125e.As it was stated, the load ramp tilt tab broke on left side causing ramp to fall.Due to the issue the operator sustained the minor injury trying to load the device.For now we do not have an information what kind of injury was it and how it happened, however we decided to report the issue in abundance of caution.

Event Description

Manufacture reference number (b)(4).

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.

Manufacturer Narrative

On 18th may, 2021 getinge became aware of an issue related to ramp used together with 91e-series washer disinfector with the serial number (b)(6) and udi number (b)(4) manufactured on 30th november, 2018.The device was installed in the facility on may 10th, 2019.The device was under getinge agreement and the last preventive maintenance was performed on 6th april, 2021.As it was stated, the customer was pushing load into the cart wash and ramp fell causing person to fall.The ramp was affected as the tilt tab broke on left side causing ramp to lower in an unintended way.When reviewing reportable events for this type we found that this is the single and first where operator fell due to affected ramp.Upon the performed investigation, getinge established that the most probable root cause of the event reported was related to the unauthorized installation as the mounted ramp type is not compatible and not validated with the 91e - series of the washer disinfectors.With the information received to date, it remains unknown how performed the installation of this part.We confirmed that the ramp was not part of the order placed for this particular customer.It was established that when the event occurred, the affected device has not performed as intended and it directly contributed to the reported event.None of the provided information indicates that upon the event occurrence the device was being used for patient treatment.The getinge product was directly involved with the reported incident.

Event Description

Manufacturer reference number: (b)(4).

• Brand Name: 91E-SERIES
• Type of Device: DISINFECTOR, MEDICAL DEVICES
• Manufacturer (Section D): GETINGE DISINFECTION AB; ljungadalsgatan 11; vaxjo
• MDR Report Key: 11998080
• MDR Text Key: 256179496
• Report Number: 9616031-2021-00013
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 08/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9125E
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/27/2021
• Patient Sequence Number: 1