86-SERIES
Report
- Report Number
- 9616031-2021-00017
- Event Type
- Malfunction
- Date Received
- June 29, 2021
- Date of Event
- June 17, 2021
- Report Date
- February 14, 2022
- Manufacturer
- GETINGE DISINFECTION AB
- Product Code
- MEC
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION.
ON 17TH JUNE, 2021 GETINGE BECAME AWARE OF AN ISSUE RELATED TO AIR GLIDE SYSTEM (AGS) USED IN THE FACILITY WITH ONE OF THE 86-SERIES WASHER DISINFECTORS. CUSTOMER REPORTED SWITCH GETTING STUCK WHAT RESULTED IN CART BEING PUSHED OFF FROM THE DEVICE. THE AGS UNLOADING DEVICE IS NOT REGISTERED AS A MEDICAL DEVICE, HOWEVER UPON THE SITUATION OCCURRENCE IT WAS BEING USED WITH WASHER DISINFECTOR 8668 AS A SYSTEM. FULLY LOADED CART FALLING OFF TO THE FLOOR COULD BRING A HAZARDOUS SITUATION FOR THE OPERATOR AND LEAD TO SERIOUS BODY INJURY IF THE SITUATION WAS TO REOCCUR, THEREFORE WE DECIDED TO REPORT THE COMPLAINT BASED ON A POTENTIAL. THE DEVICE INVOLVED IN THE INCIDENT HAS BEEN IDENTIFIED AS A NON-MEDICAL DEVICE ¿ AIR GLIDE SYSTEM (AGS) WITH SERIAL NUMBER: (B)(6) MANUFACTURED ON 15TH MAY, 2019. IN THIS PARTICULAR CASE AGS WAS USED AS A SYSTEM WITH 6 WASHER DISINFECTORS, 8668 MODELS WITH FOLLOWING SERIAL NUMBERS : (B)(6) . AGS WAS NOT DOCKED DIRECTLY TO ANY OF THE WASHERS AS THE UNLOADING TABLE/ CONVEYOR IS A STAND ALONE TABLE, THERE IS A SHUTTLE WHICH AS A PART OF AGS SYSTEM PICKS UP THE WASH CARTS FROM THE WASHERS AND TRANSFER IT TO THE TABLE. AS IT WAS STATED BY THE GETINGE SERVICE TECHNICIAN, WHO VISITED THE SITE AFTER THE EVENT OCCURRENCE, THE SWITCH (PART OF THE DOCKING ASSEMBLY) WAS FOUND TO BE MALFUNCTIONING, SO DID NOT WORK AS INTENDED. THE DOCKING ASSEMBLY CONTAINS OF DOCKING PIN AND DOCKING SENSOR TO CONTROL WHETHER THE TROLLEY IS CORRECTLY DOCKED TO THE CONVEYER, AS WELL AS A STOP PIN WHICH FUNCTION IS TO STOP THE WASH CART AND PREVENT IT FROM FALLING OFF THE CONVEYOR WHEN THE TROLLEY IS NOT DOCKED IN PLACE. WHEN THE DOCKING SENSOR WAS IN THE DOWN POSITION IT WAS GIVING FALSE SIGNAL THAT THE TROLLEY IS DOCKED PROPERLY WHEN IT WAS NOT. THIS LED TO THE HAZARDOUS SITUATION WHERE THE CART FALL OFF FROM THE UNLOADER. DURING THE INVESTIGATION IT WAS ESTABLISHED THAT THIS PARTICULAR AGS AUTOMATION LOADING SYSTEM IS NOT UNDER THE GETINGE SERVICE CONTRACT. AS CONFIRMED BY THE SERVICE TECHNICIAN THIS MEAN AS WELL THAT THERE HAS BEEN NO MAINTENANCE BY GETINGE PERSONNEL OR TRAINED STAFF PERFORMED ON THE AGS. BASED ON INFORMATION GATHERED AND THE DEVICE LABELING, THE PERIODIC MAINTENANCE AND SYSTEM TESTING MUST BE PERFORMED TO ENSURE SAFETY AND PROPER OPERATION OF THE AGS. AS STATED IN THE MANUAL STOP PIN FOR UNLOADING SHOULD BE CHECKED ON YEARLY INTERVALS TO ENSURE ITS PROPER FUNCTIONALITY. THE ISSUE WAS CONSULTED WITH THE SUBJECT MATTER EXPERT FROM THE MANUFACTURING SITE AND AS A RESULT OF THE PERFORMED INVESTIGATION, THE MOST PROBABLE ROOT CAUSE WAS ESTABLISHED AS BEING RELATED TO USER ERROR, AS IT WAS CONFIRMED THAT THE MANUAL WAS NOT FOLLOWED AND THE PREVENTIVE MAINTENANCE WAS NOT PERFORMED FOR THE DEVICE IN QUESTION. WE BELIEVE THAT IF THE MAINTENANCE SCHEDULE IS FOLLOWED ALL ISSUES RELATED TO DOCKING SWITCH/ STOP PIN ARE TO BE FOUND AND ADDRESSED TIMELY. IT WAS ESTABLISHED THAT WHEN THE EVENT OCCURRED, THE AFFECTED DEVICE DID NOT MEET ITS SPECIFICATION AS A MALFUNCTION OF THE DOCKING SENSOR OCCURRED AND LED TO THE SITUATION THAT THE CART WAS NEARLY TO FALL AND IN THIS WAY THE DEVICE CONTRIBUTED TO REPORTABLE EVENT. NONE OF THE PROVIDED INFORMATION INDICATES THAT UPON THE EVENT OCCURRENCE THE DEVICE WAS BEING USED FOR PATIENT TREATMENT. THE PROBLEM HAS BEEN RESOLVED BY LUBRICATION OF THE DOCKING SWITCH ON THE CONVEYOR GETINGE SHALL CONTINUE TO MONITOR FOR ANY FURTHER EVENTS OF THIS NATURE AND DO NOT PROPOSE ANY FURTHER ACTION AT THIS TIME.
ACCORDING TO THE REPORTING TIMEFRAME WE WOULD LIKE TO PROVIDE THE INFORMATION ABOUT CURRENT STATUS OF THE ISSUE. PLEASE BE ADVISED THAT IT IS BEING INVESTIGATED. ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION.
MANUFACTURER'S REFERENCE NUMBER: (B)(4).
MANUFACTURER REFERENCE NUMBER: (B)(4).
MANUFACTURER'S REFERENCE NUMBER: (B)(4).
ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION.
ON 17TH JUNE, 2021 GETINGE BECAME AWARE OF AN ISSUE WHERE THE SWITCH ON THE UNLOADING DEVICE WAS STUCK AND AS A CONSEQUENCE OF THIS MALFUNCTION, CART FELL OFF TO THE FLOOR. AS IT WAS CONFIRMED, THERE WAS NO DAMAGE TO THE EQUIPMENT AND THE CART. THERE WAS ALSO NO INJURY REPORTED AS AN ADVERSE OUTCOME FOR THIS OCCURRENCE. THE UNLOADING DEVICE IS NOT REGISTERED AS A MEDICAL DEVICE, HOWEVER UPON THE SITUATION OCCURRENCE IT WAS BEING USED WITH WASHER DISINFECTOR 8668 AS A SYSTEM. FULLY LOADED CART FALLING OFF TO THE FLOOR COULD BRING A HAZARDOUS SITUATION FOR THE OPERATOR AND LEAD TO SERIOUS BODY INJURY IF THE SITUATION WAS TO REOCCUR, THEREFORE WE DECIDED TO REPORT THE COMPLAINT BASED ON A POTENTIAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 984029 | 86-SERIES | DISINFECTOR, MEDICAL DEVICES | MEC | GETINGE DISINFECTION AB | 8668 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |