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

Model Number	8668
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	Electric Shock (2554)
Date of Event	01/26/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information will be provided following the conclusion of the investigation.
Event or Problem Description
A customer reported an incident in which a staff member allegedly experienced an electric shock while attempting to replace soap in the unit.According to the allegation, the individual lost consciousness and was subsequently transported to the emergency room.Additional information obtained from follow-up communication indicates that the staff member may have been attempting to address a drain-related issue at the time of the incident.The individual was hospitalized for approximately three days and remained under medical supervision, although specific diagnostic procedures and findings were not provided.No medical leave was reported following discharge.A service technician was dispatched to the site to investigate the reported event.Upon arrival, the technician observed that the service panel adjacent to the washer had been removed.A comprehensive inspection of the equipment was conducted, including verification of circuit breakers (no tripped breakers found), inspection for signs of overheating or electrical damage (no abnormal odors or burned components detected), and assessment of wiring and connections, including incoming three-phase power and grounding.All connections were found to be secure and within normal condition.The unit was subsequently operated through a full test cycle, during which all outputs and functions were verified to be operating as intended.No abnormalities or malfunctions were identified during testing.Based on the on-site investigation and functional verification, the equipment was determined to be operating properly at the time of inspection.The device was cleared for continued use.
Event or Problem Description
Manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
A customer reported an incident in which a staff member allegedly experienced an electric shock, leading to loss of consciousness and hospitalization for three days.Initially, it was reported that the incident occurred while attempting to replace soap in the unit, although later information suggested that the individual may have been addressing a drain-related issue rather than replacing soap.An on-site investigation found no evidence of electrical malfunction, all systems were functioning correctly, and no possible cause could be confirmed, with the device deemed safe for continued use and no similar incidents reported.The investigation conducted by the subject matter expert, in collaboration with the getinge field technician and the getinge ssu site, determined that the customer had removed a service panel to access a restricted internal area of the machine, which is explicitly prohibited for non-qualified personnel according to the user manual.No product defect, manufacturing issue, or design failure was identified, and the incident was concluded to have resulted from unauthorized access by the customer, therefore no corrective or preventive actions are required from getinge.The results of this investigation was shared with the customer in order for them to avoid the recurrence of similar situation in the future.At this stage, no further action towards the manufacturing process or marketed devices is warranted.However, getinge will continue to closely monitor customer feedback and field performance of the device for any future information that may require additional action.

• 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: emelie szabo ; ljungadalsgatan 11; vaxjo
• MDR Report Key: 24857978
• Report Number: 9616031-2026-0000008
• Device Sequence Number: 18765195
• Product Code: MEC
• UDI-Device Identifier: 07340153700277
• UDI-Public: (01)07340153700277
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2026

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
• Operator of Device: Health Professional
• Device Model Number: 8668
• Device Catalogue Number: S-86682003-CTOM
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2026
• Supplement Date Received by Manufacturer: 06/01/2026
• Initial Report FDA Received Date: 04/13/2026
• Supplement Report FDA Received Date: 06/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/31/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown