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

Model Number 9125E

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Loss of Range of Motion (2032)

Event Date 01/17/2023

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 24th february, 2023 getinge received the information about the event which was related to the manual trolley used with the 91e-series washer disinfector.The event occurred on (b)(6) 2023.As it was stated the staff member felt a pain in her right ankle while pushing cart from the washer disinfector from the decontamination site.The operator sustained an injury.The incident occurred when the wash cart was maximally loaded.The medical intervention was provided and the 2 days medical leave was needed.Additionally, the operator activities at work and at home from (b)(6) 2023 to (b)(6) 2023 were modified to avoid temporary and complete disable from the regular work for the designated time.The patient is allowed to lift/ carry/ push/ pull no more than 10 pounds.The operator needs to use brace and received concurrent treatment: consult/ referral.As additional restriction only sit down duty was recommended.So far, there is no further information about health condition provided.Based on the available information we decided to report the issue in abundance of caution as we cannot confirm that similar events could not contributed to the serious injury if 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: 16608666
• MDR Text Key: 312288754
• Report Number: 9616031-2023-00012
• Device Sequence Number: 1
• Product Code: MEC
• UDI-Device Identifier: 07340153710047
• UDI-Public: (01)07340153710047
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 9125E
• Device Catalogue Number: 9125E-001
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/24/2023
• Initial Date FDA Received: 03/24/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/09/2019
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female