9100-SERIES
Report
- Report Number
- 9616031-2017-00032
- Event Type
- Malfunction
- Date Received
- December 4, 2017
- Date of Event
- November 24, 2017
- Report Date
- March 21, 2018
- Manufacturer
- GETINGE DISINFECTION AB
- Product Code
- MEC
- UDI-DI
- 07340153710023
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
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.
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.
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).
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.
MANUFACTURER'S REFERENCE NUMBER (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 858578 | 9100-SERIES | DISINFECTOR, MEDICAL DEVICES | MEC | GETINGE DISINFECTION AB | 9120 | 07340153710023 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male | Other |