86-SERIES
Report
- Report Number
- 9616031-2021-00015
- Event Type
- Malfunction
- Date Received
- June 18, 2021
- Report Date
- September 7, 2021
- Manufacturer
- GETINGE DISINFECTION AB
- Product Code
- MEC
- UDI-DI
- 07340153700277
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SW
- Reporter Occupation
- OTHER
Narratives
THE PURPOSE OF THIS SUBMISSION IS SOLELY TO PROVIDE A CORRECTION OF ADDTL MFG NARRATIVE/CORR. DATA SECTION. THIS IS BASED ON THE RESULT OF AN INTERNAL REVIEW NOTING THE REPORT DID NOT CONTAIN AVAILABLE INFORMATION. PREVIOUS ADDTL MFG NARRATIVE/CORR. DATA: ON 8TH JUNE, 2021 GETINGE BECAME AWARE OF AN ISSUE RELATED TO FREE STANDING UNLOADING CONVEYOR (FSUC) USED TOGETHER WITH 86-SERIES WASHER DISINFECTOR. AS IT WAS STATED, SINCE THE UNLOADER WAS INSTALLED IN JANUARY, 2021, IT WAS USED DAILY. THERE WAS NO INJURY OR FACILITY DAMAGE REPORTED, HOWEVER WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY RELATED TO A LOAD FALL SHOULD THE SITUATION WAS TO REOCUR THE DEVICE INVOLVED WAS A FREE STANDING UNLOADING CONVEYOR (FSUC) WITH SERIAL NUMBER: (B)(6) INSTALLED IN JANUARY, 2021. THE DEVICE IS USED WITH THE 8668 WASHER DISINFECTOR WITH THE SERIAL NUMBER WAA096955 AND UDI NUMBER MANUFACTURED ON 20TH AUGUST, 2020. THE GETINGE SERVICE TECHNICIAN VISITED THE FACILITY AFTER THE ALLEGED SITUATION TOOK PLACE. THE FUNCTIONALITY AND STATE OF THE DEVICE INDICATED AS FAULTY WAS CHECKED AND NO MALFUNCTION COULD BE FOUND. DESPITE THE EFFORT, THE SERVICE TECHNICIAN WAS NOT ABLE TO FIND TO DUPLICATE THE ALLEGED ISSUE. AS NO MORE INFORMATION COULD HAVE BEEN OBTAINED, THE PERFORMED INVESTIGATION WAS CONCLUDED WITH A ROOT CAUSE AS IMPOSSIBLE TO BE DEFINED. IT WAS ESTABLISHED THAT WHEN THE EVENT OCCURRED, THE AFFECTED DEVICE WAS ALLEGED TO HAVE MALFUNCTIONED SINCE IT WAS ALLEGED TO HAVE SENT CARTS ON THE GROUND, HOWEVER NO MECHANICAL MALFUNCTION WAS CONFIRMED BY THE QUALIFIED PERSONNEL UPON DEVICE INSPECTION. NONE OF THE PROVIDED INFORMATION INDICATES THAT UPON THE EVENT OCCURRENCE THE DEVICE WAS BEING USED FOR PATIENT TREATMENT. CORRECTED ADDTL MFG NARRATIVE/CORR. DATA: AS A RESULT OF AN INTERNAL REVIEW, THE CONCLUSION WAS UPDATED. ON 8TH JUNE, 2021 GETINGE BECAME AWARE OF AN ISSUE RELATED TO FREE STANDING UNLOADING CONVEYOR (FSUC) WITH SERIAL NUMBER: (B)(6) INSTALLED IN JANUARY, 2021 USED TOGETHER WITH 86-SERIES WASHER DISINFECTOR WITH THE SERIAL NUMBER WAA096955 AND UDI NUMBER (01)07340153700277 MANUFACTURED ON 20TH AUGUST, 2020. AS IT WAS STATED, SINCE THE UNLOADER WAS INSTALLED IN JANUARY, 2021, IT WAS USED DAILY. THERE WAS NO INJURY OR DAMAGE REPORTED, HOWEVER WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION WAS TO REOCCUR. THE GETINGE SERVICE TECHNICIAN VISITED THE FACILITY AFTER THE ALLEGED SITUATION TOOK PLACE. THE TECHNICIAN CHECKED FUNCTIONALITY AND STATE OF THE DEVICE AND ITS ACCESSORY WHICH CONTRIBUTED TO THE EVENT BUT NO MALFUNCTION COULD BE FOUND. DESPITE THE EFFORT, THE SERVICE TECHNICIAN WAS NOT ABLE TO FIND THE FAULT OR DUPLICATE THE ISSUE. AS NO MORE INFORMATION COULD HAVE BEEN OBTAINED AND ISSUE COULD NOT BE DUPLICATED, A ROOT CAUSE OF THE PERFORMED INVESTIGATION WAS IMPOSSIBLE TO BE DEFINED. IT WAS ESTABLISHED THAT WHEN THE EVENT OCCURRED, THE AFFECTED DEVICE HAS NOT PERFORMED AS INTENDENT, HOWEVER NO MECHANICAL MALFUNCTION HAS BEEN FOUND UPON DEVICE INSPECTION. NONE OF THE PROVIDED INFORMATION INDICATES THAT UPON THE EVENT OCCURRENCE THE DEVICE WAS BEING USED FOR PATIENT TREATMENT.
ON 8TH JUNE, 2021 GETINGE BECAME AWARE OF AN ISSUE RELATED TO FREE STANDING UNLOADING CONVEYOR (FSUC) USED TOGETHER WITH 86-SERIES WASHER DISINFECTOR. AS IT WAS STATED, SINCE THE UNLOADER WAS INSTALLED IN JANUARY, 2021, IT WAS USED DAILY. THERE WAS NO INJURY OR FACILITY DAMAGE REPORTED, HOWEVER WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY RELATED TO A LOAD FALL SHOULD THE SITUATION WAS TO REOCCUR THE DEVICE INVOLVED WAS A FREE STANDING UNLOADING CONVEYOR (FSUC) WITH SERIAL NUMBER: (B)(6) INSTALLED IN JANUARY, 2021. THE DEVICE IS USED WITH THE 8668 WASHER DISINFECTOR WITH THE SERIAL NUMBER (B)(6) AND UDI NUMBER MANUFACTURED ON 20TH AUGUST, 2020. THE GETINGE SERVICE TECHNICIAN VISITED THE FACILITY AFTER THE ALLEGED SITUATION TOOK PLACE. THE FUNCTIONALITY AND STATE OF THE DEVICE INDICATED AS FAULTY WAS CHECKED AND NO MALFUNCTION COULD BE FOUND. DESPITE THE EFFORT, THE SERVICE TECHNICIAN WAS NOT ABLE TO FIND TO DUPLICATE THE ALLEGED ISSUE. AS NO MORE INFORMATION COULD HAVE BEEN OBTAINED, THE PERFORMED INVESTIGATION WAS CONCLUDED WITH A ROOT CAUSE AS IMPOSSIBLE TO BE DEFINED. IT WAS ESTABLISHED THAT WHEN THE EVENT OCCURRED, THE AFFECTED DEVICE WAS ALLEGED TO HAVE MALFUNCTIONED SINCE IT WAS ALLEGED TO HAVE SENT CARTS ON THE GROUND, HOWEVER NO MECHANICAL MALFUNCTION WAS CONFIRMED BY THE QUALIFIED PERSONNEL UPON DEVICE INSPECTION. NONE OF THE PROVIDED INFORMATION INDICATES THAT UPON THE EVENT OCCURRENCE THE DEVICE WAS BEING USED FOR PATIENT TREATMENT.
MANUFACTURER REFERENCE NUMBER (B)(4).
MANUFACTURER REFERENCE NUMBER (B)(4).
ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION.
ON 8TH JUNE, 2021 GETINGE BECAME AWARE OF AN ISSUE RELATED TO UNLOADING DEVICE USED TOGETHER WITH 86-SERIES WASHER DISINFECTOR. AS IT WAS STATED, THE UNLOADER MALFUNCTIONED RESULTING CARTS FELL TO THE FLOOR 2 TIMES. THERE WAS NO INJURY REPORTED, HOWEVER WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION THAT ANY CART FALLING OF THE DEVICE COULD CAUSE AN INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 924743 | 86-SERIES | DISINFECTOR, MEDICAL DEVICES | MEC | GETINGE DISINFECTION AB | 8668 | 07340153700277 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |