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

Model Number 9128E

Device Problem Device Dislodged or Dislocated (2923)

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

Event Date 11/21/2022

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 21st november, 2022 getinge became aware of an issues related to manual trolley.The manual trolley is not registered as a medical device, however upon the situation occurrence it was used with the medical device washer disinfector with the model name 9128e.As it was stated, the loading trolley almost fell on the floor due to a faulty stop pin that is installed on the manual trolley to prevents the loading trolleys from falling off.The malfunctioned part was replaced and the manual trolley was returned to the service in full working condition.There was no injury or damage reported, however we decided to report the issue based on a potential as loading trolley falling to the floor could bring a hazardous situation for the operator and lead to serious injury if the situation was to reoccur.

• Brand Name: 91E-SERIES
• 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: dennis genito ; ljungadalsgatan 11; vaxjo
• MDR Report Key: 15894321
• MDR Text Key: 307780678
• Report Number: 9616031-2022-00028
• Device Sequence Number: 1
• Product Code: MEC
• UDI-Device Identifier: 07340153710061
• UDI-Public: (01)07340153710061
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 12/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 9128E
• Device Catalogue Number: 9128E-001
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/21/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/28/2020
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1