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

Model Number	8668
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	Skin Tears (2516)
Date of Event	06/29/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On june 30th, 2022 getinge became aware of an issue with one of the washer-disinfectors with the model name: 8668.As it was stated, on (b)(6) 2022, the operator of the device cut their hand on sharp edges of the cleaning rack.So far, we have not been informed about any serious injury as a consequence of the event, however we decided to report the issue in abundance of caution and based on the potential for serious injury if the situation was to reoccur.
Additional Manufacturer Narrative
Additional information will be provided following the conclusion of the investigation.Device not returned to the manufacturer.
Event or Problem Description
Manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
On june 30th, 2022 getinge became aware of an issue with one of the 86-series washer-disinfectors with the model name: 8668.As it was stated, on (b)(6) 2022, the operator of the device cut their hand on a sharp edge of the cleaning rack.We decided to report the issue in abundance of caution and based on the potential for serious injury if the situation was to reoccur.Trend review of customer product complaints with the same issue involved on 86-series, 88-series, 90/91-series, 91e-series and automation loading system devices reported within the last 5 years was performed but did not provide any relevant increase in occurrence rate or other signals that triggered further scrutiny.The result of our investigation allows us to conclude that problem is a consequence of the failure during assembly work in the supplier process.A getinge service technician visited the customer site, resolved the problem and returned the accessory for usage, which is now fully operational.When the incident occurred, the device was directly involved.The device did not meet its specification.Upon the event occurrence the device was not being used for patient treatment or diagnosis.We believe that devices in the market are performing correctly overall.Given the circumstances we shall continue to monitor for any further events of this nature.

• Brand Name: 86-SERIES
• Common Device Name: 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: 14927994
• Report Number: 9616031-2022-00016
• Device Sequence Number: 11270462
• Product Code: MEC
• UDI-Device Identifier: 07340153700277
• UDI-Public: (01)07340153700277
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/06/2022

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 Model Number: 8668
• Device Catalogue Number: S-86682003-CTOM
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2022
• Supplement Date Received by Manufacturer: 12/14/2023
• Initial Report FDA Received Date: 07/06/2022
• Supplement Report FDA Received Date: 12/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/02/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown