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

Model Number 8668

Device Problem Device Fell (4014)

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

Event Date 01/15/2024

Event Type  malfunction  

Event Description

On january 16, 2024 getinge became aware of an issue with a loading trolley with a serial number: (b)(6), which was used with one of three 86-series washer-disinfectors with serial numbers: (b)(6).A customer allegation was that the trolley is missing stopper.Getinge technician visited site and was informed that the trolley had been pushed onto the loader incorrectly and had fallen on the floor snapping of one of the arms on the carrier.So far, we have not been informed about any adverse consequences of reported issue, however we decided to report the issue based on the potential as the trolley falling to the ground may result in a serious injury if the situation was to reoccur.

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.H3 other text : device not returned to the manufacturer.

• Brand Name: 86-SERIES WASHER DISINFECTOR
• Type of Device: DISINFECTOR, MEDICAL DEVICES
• Manufacturer (Section D): GETINGE DISINFECTION AB; ljungadalsgatan 11; vaxjo
• Manufacturer (Section G): GETINGE DISINFECTION AB; ljungadalsgatan 11; vaxjo
• Manufacturer Contact: tina evancho ; ljungadalsgatan 11; vaxjo
• MDR Report Key: 18666310
• MDR Text Key: 334845821
• Report Number: 9616031-2024-00004
• Device Sequence Number: 1
• Product Code: MEC
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/08/2024

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: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/16/2024
• Initial Date FDA Received: 02/08/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/05/2021
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1