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

Model Number 8668

Device Problem Chemical Problem (2893)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/21/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On (b)(6) 2021 getinge became aware of an issue with one of the washer-disinfectors with the model name: 8668.The first customer allegation was that the pink film was leaved on the instruments.On (b)(6) 2021 it was reported by the customer that the unit did not pass the wash check test.During the service the technician noticed issues with slow pumping of the detergent and switched detergent hoses (resulting of pumping the lubricant instead of wash detergent).The issues which were found have been fixed and the device was returned to use in fully operational state.There was no injury reported, however we decided to report the issue as we were not able to establish for how long the detergents dosing was incorrect and if the loads affected were used.Therefore, we based on the potential as the issue may affect the final result of the cleaning process and the uncleaned good may have been used to the patients treatment.

Manufacturer Narrative

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

Event Description

Manufacturer reference number (b)(4).

• Brand Name: 86-SERIES
• Type of Device: DISINFECTOR, MEDICAL DEVICES
• Manufacturer (Section D): GETINGE DISINFECTION AB; ljungadalsgatan 11; vaxjo
• MDR Report Key: 12315380
• MDR Text Key: 266408018
• Report Number: 9616031-2021-00023
• 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
• Report Date: 09/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8668
• Device Catalogue Number: S-86682003-CTOM
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/21/2021
• Initial Date FDA Received: 08/12/2021
• Supplement Dates Manufacturer Received: 09/02/2021
• Supplement Dates FDA Received: 09/27/2021
• Patient Sequence Number: 1