MAUDE Adverse Event Report: GETINGE DISINFECTION AB 9100-SERIES; DISINFECTOR, MEDICAL DEVICES

Model Number	9120
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/24/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being filed under exemption e2016015 by the manufacturer getinge disinfection ab, (registration no.9616031) on behalf of the importer getinge usa, inc., (registration no.3004147784).Additional information will be provided upon results of the investigation.
Event or Problem Description
On (b)(6) we become aware of an incident where one of our medical device was involved.Per information provided by the customer it was established that during preventive maintenance performed on the 9100-series washer disinfector the technician went inside the washer chamber to check and clean the filters of the chamber and did not lock door with key switch.In the same time operator of the device started the cycle.Technician who was inside the chamber stopped machine immediately and as a result he was splashed with cold water.No injury has been reported, however we decided to report this case in abundance of caution.
Additional Manufacturer Narrative
This report is being filed under exemption e2016015 by the manufacturer getinge disinfection ab, (registration no.9616031) on behalf of the importer getinge usa, inc., (registration no.3004147784).Getinge became aware of an event where it was stated that during the preventive maintenance the technician went inside the chamber to clean filters.In the same time the operator of the device started the washing cycle.Technician who was inside the chamber stopped machine with the safety line immediately and as a result he was splashed with cold water.The investigation on this issue has been performed.The root cause of the investigated herein issue has been established as user error as the technician entered the chamber without locking the key switch and the operator of the device run the cycle when the technician was inside.User manual for getinge 9100-series (6001341202, rev.D) includes description of the controls presented on the device and an information about key switch responsibility for locking the doors door operation when switched to the lock position.The same user manual includes warning in case of entering the chamber and it states as follow: "before entering the chamber the key switch for the door operation must be switched to the lock position.Operator must keep the key while inside the chamber." we believe if the technician would have followed the instruction included in user manual, and lockout the key switch this would have avoided this event.At the time of the event the device was up to specification and it contributed to the outcomes of the event.No injury was reported as a result of the incident.However we decided to report this is abundance of caution.
Additional Manufacturer Narrative
The follow up report (mfr report number 9616031-2017-00032) is submitted due to the missing f/u 1and it is submitted to correct the error in numbering.There is no new information regarding this case.The final report (f/u 2, 3004147784-2017-00032) was sent on 21/03/2018.The date received by mfg is the date when the fda request was received (03/04/2025).
Event or Problem Description
Manufacturer's reference number (b)(4).

• Brand Name: 9100-SERIES
• Common Device Name: DISINFECTOR, MEDICAL DEVICES
• Manufacturer (Section D): GETINGE DISINFECTION AB; ljungadalsgatan 11; vaxjo kronobergs ian [se-07]; vaxjo, 35115 ; SW 35115
• Manufacturer (Section G): GETINGE DISINFECTION AB; ljungadalsgatan 11; vaxjo kronobergs ian [se-07]; vaxjo, 35115 ; SW 35115
• Manufacturer Contact: dennis genito ; 45 barbour pond drive; wayne, NJ 07470 ; 9737097515
• MDR Report Key: 7078692
• Report Number: 9616031-2017-00032
• Device Sequence Number: 1260951
• Product Code: MEC
• UDI-Device Identifier: 07340153710023
• UDI-Public: 07340153710023
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2018
• Report Date (Section F): 12/04/2017

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: 9120
• Device Catalogue Number: 9120-002
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/24/2017
• Device Age: 3 YR
• Event Location: Hospital
• Date Report to Manufacturer: 12/04/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/24/2017
• Supplement Date Received by Manufacturer: 04/03/2025
• Initial Report FDA Received Date: 12/04/2017
• Supplement Report FDA Received Date: 04/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Date Report Sent to FDA: 12/04/2017