MAUDE Adverse Event Report: GETINGE DISINFECTION AB 88-SERIES; DISINFECTOR, MEDICAL DEVICES

Model Number 88-5

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/21/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On (b)(6) 2019 getinge became aware about ans issue with unloader used with one of the washer disinfector- 88-5 model number.As it as stated, the cart was pushed off the unloader due to missing magnets on wash racks.There was no injury reported, however it was decided to report this issue based on the potential, as any cart falling off the unloader might led to an adverse event.The unloader is not being registered as a medical device, however it was used with washer disinfector as a system and the issue will be reported such as.

Manufacturer Narrative

The issue is still being investigated by manufacturing site.

Event Description

Manufacturer reference number: (b)(4).

Manufacturer Narrative

The issue is still being investigated by manufacturing site.

Event Description

Manufacturer reference nimber (b)(4).

Manufacturer Narrative

The issue is still being investigated by manufacturing site.

Event Description

Manufacturer reference number: (b)(4).

Manufacturer Narrative

The issue is still being investigated by manufacturing site.

Event Description

Manufacturer reference number: (b)(4).

Manufacturer Narrative

When reviewing reportable events for this type of issues we were able to establish that the received incident is first one registered for issue with cart falling off the device due to missing magnets.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.The carts affected by this issue were new and ordered by the customer on 25th july, 2019 to be used together with 88-5 washer disinfector.During the investigation course, we were able to establish that the cart was pushed off the unloader as it did not recognize the cart while reaching the end of unloading equipment.This happened due to missing magnets on the newly ordered wash racks, as this specific kit was not included while ordering the rack.The installation of the rack was performed by the customer.After recognizing the issue, the customer raised a complaint to getinge and company¿s representative visited the site.He was able to identify the problem, order and install the missing magnets and return the device to the customers¿ usage.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 reference number (b)(4).

• Brand Name: 88-SERIES
• Type of Device: DISINFECTOR, MEDICAL DEVICES
• Manufacturer (Section D): GETINGE DISINFECTION AB; ljungadalsgatan 11; vaxjo
• MDR Report Key: 8959674
• MDR Text Key: 156438080
• Report Number: 9616031-2019-00026
• 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,Followup
• Report Date: 01/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 88-5
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1