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

Model Number 9125E

Device Problem Mechanical Jam (2983)

Patient Problem Loss of Range of Motion (2032)

Event Date 11/17/2022

Event Type  malfunction  

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) 2022.As it was stated staff member was unloading the cart on the clean side.The wheels of the cart turned sideways inside the washer disinfector and the staff member had to pull harder to get the cart out.The injury occurred when the wash cart was maximally loaded.The medical intervention was provided and the 2 days of sick leave was needed.Additionally, the operator activities at work and at home from (b)(6) 2022 to (b)(6) 2022 have been modified to avoid temporary and complete disable from the regular work for the designated time: cannot reach above right shoulder, cannot make repetitive movements with the right hand.As additional restrictions were defined: no use of right arm/ hand, no lifting and the need of use the sling.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.

Manufacturer Narrative

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

• 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: 16608667
• MDR Text Key: 312301320
• Report Number: 9616031-2023-00011
• 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?: Yes
• 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