88-SERIES
Report
- Report Number
- 9616031-2021-00034
- Event Type
- Injury
- Date Received
- November 8, 2021
- Date of Event
- October 27, 2021
- Report Date
- January 27, 2022
- Manufacturer
- GETINGE DISINFECTION AB
- Product Code
- MEC
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
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. THE PURPOSE OF THIS SUBMISSION IS ALSO TO PROVIDE A CORRECTION OF THE FIELD #B5. DESCRIBE EVENT OR PROBLEM PREVIOUS #B5. DESCRIBE EVENT OR PROBLEM ON 28TH OCTOBER, 2021 GETINGE BECAME AWARE OF AN EVENT THAT TOOK PLACE ON (B)(6) 2021. THERE WAS AN ISSUE WITH ONE OF THE NON MEDICAL DEVICE - TROLLEY USED TOGETHER WITH THE 88-SERIES WASHER DISINFECTOR. AS IT WAS STATED, THE LOAD FELL OF THE HANDLING TROLLEY DUE TO MISSING REAR SAFETY STOPPER AND RETRACTABLE FINGER DUE TO THE BROKEN BLOCKAGE. IN CONSEQUENCE, THE OPERATOR BROKE A TOE ON HIS RIGHT FOOT AND HAD CONTUSION ON LEG AND SHOULDER. THE INJURY WAS CLASSIFIED AS SERIOUS. THE INFORMATION PROVIDED CONFIRMS THAT THE OPERATOR HAS FROM 3 TO 6 WEEKS BREAK FROM WORK. CORRECTED #B5. DESCRIBE EVENT OR PROBLEM ON 28TH OCTOBER, 2021 GETINGE BECAME AWARE OF AN EVENT THAT TOOK PLACE ON (B)(6) 2021. THERE WAS AN ISSUE WITH ONE OF THE NON MEDICAL DEVICE - TROLLEY USED TOGETHER WITH THE 88-SERIES WASHER DISINFECTOR. AS IT WAS STATED, THE LOAD FELL OF THE HANDLING TROLLEY DUE TO MISSING REAR SAFETY STOPPER AND RETRACTABLE FINGER DUE TO THE BROKEN BLOCKAGE. IN CONSEQUENCE, THE OPERATOR BROKE A TOE ON HIS RIGHT FOOT AND HAD CONTUSION ON LEG AND SHOULDER. THE INJURY WAS CLASSIFIED AS SERIOUS. THE INFORMATION PROVIDED CONFIRMS THAT THE OPERATOR HAS FROM 3 TO 6 WEEKS BREAK FROM WORK. RECEIVED ACCIDENT REPORT INDICATES THAT THE STAFF MEMBER TOOK THE UNLOADING TROLLEY AND TOOK OUT THE BASE OF THE WASHER-DISINFECTOR. WHEN SHE PULLED IT TOWARDS HER, THE BASE SLIPPED OFF THE MANUAL TROLLEY AND FELL ONTO HER ARM, SHOULDER, HAND AND FIFTH TOE OF THE LEFT FOOT. THE FIFTH TOE OF THE LEFT FOOT WAS FRACTURED. THE BASE FELL ON THE GROUND (IT CONTAINED OPERATING ROOM EQUIPMENT). THE INJURED PERSON HAD SICK LEAVE UNTIL (B)(6) 2021.
THE REVIEW OF REPORTABLE EVENTS REGISTERED GETINGE DEVICES¿ MANUAL TROLLEY (A DEVICE ACCESSORY) REPORTED TO COMPANY¿S COMPLAINT HANDLING SYSTEM WITHIN LAST 5 YEARS WAS PERFORMED. IT REVEALED THAT THE COMPLAINT IS ONE OF SEVERAL REPORTED CASES WITH THE ALLEGATION ABOUT CART, RACK OR INSTRUMENTS FALLING OR NEARLY FALLING FROM THE MANUAL TROLLEY DUE TO VARIOUS REASONS. AS IT WAS PROVIDED IN THE COMPLAINT RECORD, THE DEVICE INVOLVED WAS A MANUAL TROLLEY, PART NUMBER 6020720171, AND MOST PROBABLY IT WAS MANUFACTURED BEFORE 2011 BY GETINGE. AT THE TIME OF EVENT OCCURRENCE, IT WAS USED TOGETHER WITH ONE OF THE 88-SERIES WASHER DISINFECTORS. LAST PREVENTIVE MAINTENANCE ON THE DEVICES INSTALLED AT THE FACILITY WAS PERFORMED AT THE BEGINNING OF OCTOBER 2021. NONE OF THE PROVIDED INFORMATION INDICATES THAT UPON THE EVENT OCCURRENCE THE DEVICE WAS BEING USED FOR PATIENT TREATMENT OR DIAGNOSIS. DURING THE INVESTIGATION, IT WAS FOUND THAT THIS COMPLAINT IS THE FIRST CASE WHERE THE REPORTED SCENARIO HAS LED TO SERIOUS INJURY. IT WAS ESTABLISHED THAT WHEN THE EVENT OCCURRED, THE MANUAL TROLLEY, WHICH IS USED AS A SYSTEM WITH WASHER DISINFECTOR 88-5, DID NOT MEET ITS SPECIFICATION AND WAS DIRECTLY INVOLVED IN REPORTED EVENT. WE WERE ALSO ABLE TO ESTABLISH, THAT THE PIN INSTALLED ON THE TROLLEY WAS MISSING AND IT CONSEQUENTLY LED TO THE SITUATION WHERE THE LOAD FELL FROM THE TROLLEY. DUE TO THIS ISSUE THE OPERATOR SUSTAINED FRACTURE OF THE FIFTH TOE OF THE LEFT FOOT. THIS INJURY MADE HER UNABLE TO WORK FOR THREE WEEKS AND SHE GOT A SICK LEAVE FROM WORK UNTIL (B)(6) 2021. A GETINGE SERVICE TECHNICIAN VISITED THE CUSTOMER SITE, RESOLVED THE PROBLEM, RE-INSTALLED THE PIN AND RETURNED THE DEVICE FOR USAGE ¿ IT IS NOW FULLY OPERATIONAL. WE BELIEVE THAT DEVICES IN THE MARKET ARE PERFORMING CORRECTLY OVERALL. GIVEN THE CIRCUMSTANCES WE SHALL CONTINUE TO MONITOR FOR ANY FURTHER EVENTS OF THIS NATURE. THE PURPOSE OF THIS SUBMISSION IS ALSO TO PROVIDE A CORRECTION OF #B5. DESCRIBE EVENT OR PROBLEM THIS IS BASED ON THE RESULT OF AN INTERNAL REVIEW. PREVIOUS #B5 DESCRIBE EVENT OR PROBLEM: ON 28TH OCTOBER, 2021 GETINGE BECAME AWARE OF AN EVENT THAT TOOK PLACE ON (B)(6) 2021. THERE WAS AN ISSUE WITH ONE OF THE NON MEDICAL DEVICE - TROLLEY USED TOGETHER WITH THE 88-SERIES WASHER DISINFECTOR. AS IT WAS STATED, THE LOAD FELL OF THE HANDLING TROLLEY DUE TO MISSING REAR SAFETY STOPPER AND RETRACTABLE FINGER DUE TO THE BROKEN BLOCKAGE. IN CONSEQUENCE, THE OPERATOR BROKE A TOE ON HIS RIGHT FOOT AND HAD CONTUSION ON LEG AND SHOULDER. THE INJURY WAS CLASSIFIED AS SERIOUS. THE INFORMATION PROVIDED CONFIRMS THAT THE OPERATOR HAS FROM 3 TO 6 WEEKS BREAK FROM WORK. RECEIVED ACCIDENT REPORT INDICATES THAT THE STAFF MEMBER TOOK THE UNLOADING TROLLEY AND TOOK OUT THE BASE OF THE WASHER-DISINFECTOR. WHEN SHE PULLED IT TOWARDS HER, THE BASE SLIPPED OFF THE MANUAL TROLLEY AND FELL ONTO HER ARM, SHOULDER, HAND AND FIFTH TOE OF THE LEFT FOOT. THE FIFTH TOE OF THE LEFT FOOT WAS FRACTURED. THE BASE FELL ON THE GROUND (IT CONTAINED OPERATING ROOM EQUIPMENT). THE INJURED PERSON HAD SICK LEAVE UNTIL (B)(6) 2021. CORRECTED #B5 DESCRIBE EVENT OR PROBLEM: ON 28TH OCTOBER, 2021 GETINGE BECAME AWARE OF AN EVENT THAT TOOK PLACE ON (B)(6) 2021. THERE WAS AN ISSUE WITH ONE OF THE NON MEDICAL DEVICE - TROLLEY USED TOGETHER WITH THE 88-SERIES WASHER DISINFECTOR. AS IT WAS STATED, THE LOAD FELL OF THE HANDLING TROLLEY DUE TO MISSING REAR SAFETY STOPPER AND RETRACTABLE FINGER DUE TO THE BROKEN BLOCKAGE. IN CONSEQUENCE, THE OPERATOR BROKE A TOE ON HIS RIGHT FOOT AND HAD CONTUSION ON LEG AND SHOULDER. THE INJURY WAS CLASSIFIED AS SERIOUS. THE INFORMATION PROVIDED CONFIRMS THAT THE OPERATOR HAS FROM 3 TO 6 WEEKS BREAK FROM WORK. RECEIVED ACCIDENT REPORT INDICATES THAT THE STAFF MEMBER TOOK THE UNLOADING TROLLEY AND TOOK OUT THE BASE OF THE WASHER-DISINFECTOR. WHEN SHE PULLED IT TOWARDS HER, THE BASE SLIPPED OFF THE MANUAL TROLLEY AND FELL ONTO HER ARM, SHOULDER, HAND AND LEFT FOOT. THE FIFTH TOE OF THE LEFT FOOT WAS FRACTURED. THE BASE FELL ON THE GROUND (IT CONTAINED OPERATING ROOM EQUIPMENT). THE INJURED PERSON HAD SICK LEAVE UNTIL (B)(6) 2021.
THE PURPOSE OF THIS SUBMISSION IS TO PROVIDE A CORRECTION OF #H10 ADDITIONAL. MANUFACTURER NARRATIVE. PREVIOUS #H10 ADDITIONAL MANUFACTURER NARRATIVE: THE REVIEW OF REPORTABLE EVENTS REGISTERED GETINGE DEVICES¿ MANUAL TROLLEY (A DEVICE ACCESSORY) REPORTED TO COMPANY¿S COMPLAINT HANDLING SYSTEM WITHIN LAST 5 YEARS WAS PERFORMED. IT REVEALED THAT THE COMPLAINT IS ONE OF SEVERAL REPORTED CASES WITH THE ALLEGATION ABOUT CART, RACK OR INSTRUMENTS FALLING OR NEARLY FALLING FROM THE MANUAL TROLLEY DUE TO VARIOUS REASONS. AS IT WAS PROVIDED IN THE COMPLAINT RECORD, THE DEVICE INVOLVED WAS A MANUAL TROLLEY, PART NUMBER 6020720171, AND MOST PROBABLY IT WAS MANUFACTURED BEFORE 2011 BY GETINGE. AT THE TIME OF EVENT OCCURRENCE, IT WAS USED TOGETHER WITH ONE OF THE 88-SERIES WASHER DISINFECTORS. LAST PREVENTIVE MAINTENANCE ON THE DEVICES INSTALLED AT THE FACILITY WAS PERFORMED AT THE BEGINNING OF OCTOBER 2021. NONE OF THE PROVIDED INFORMATION INDICATES THAT UPON THE EVENT OCCURRENCE THE DEVICE WAS BEING USED FOR PATIENT TREATMENT OR DIAGNOSIS. DURING THE INVESTIGATION, IT WAS FOUND THAT THIS COMPLAINT IS THE FIRST CASE WHERE THE REPORTED SCENARIO HAS LED TO SERIOUS INJURY. IT WAS ESTABLISHED THAT WHEN THE EVENT OCCURRED, THE MANUAL TROLLEY, WHICH IS USED AS A SYSTEM WITH WASHER DISINFECTOR 88-5, DID NOT MEET ITS SPECIFICATION AND WAS DIRECTLY INVOLVED IN REPORTED EVENT. WE WERE ALSO ABLE TO ESTABLISH, THAT THE PIN INSTALLED ON THE TROLLEY WAS MISSING AND IT CONSEQUENTLY LED TO THE SITUATION WHERE THE LOAD FELL FROM THE TROLLEY. DUE TO THIS ISSUE THE OPERATOR SUSTAINED FRACTURE OF THE FIFTH TOE OF THE LEFT FOOT. THIS INJURY MADE HER UNABLE TO WORK FOR THREE WEEKS AND SHE GOT A SICK LEAVE FROM WORK UNTIL NOVEMBER 17TH, 2021. A GETINGE SERVICE TECHNICIAN VISITED THE CUSTOMER SITE, RESOLVED THE PROBLEM, RE-INSTALLED THE PIN AND RETURNED THE DEVICE FOR USAGE ¿ IT IS NOW FULLY OPERATIONAL. WE BELIEVE THAT DEVICES IN THE MARKET ARE PERFORMING CORRECTLY OVERALL. GIVEN THE CIRCUMSTANCES WE SHALL CONTINUE TO MONITOR FOR ANY FURTHER EVENTS OF THIS NATURE. CORRECTED #H10 ADDITIONAL MANUFACTURER NARRATIVE: THE REVIEW OF REPORTABLE EVENTS REGISTERED GETINGE DEVICES¿ MANUAL TROLLEY (A DEVICE ACCESSORY) REPORTED TO COMPANY¿S COMPLAINT HANDLING SYSTEM WITHIN LAST 5 YEARS WAS PERFORMED. IT REVEALED THAT THE COMPLAINT IS ONE OF SEVERAL REPORTED CASES WITH THE ALLEGATION ABOUT CART, RACK OR INSTRUMENTS FALLING OR NEARLY FALLING FROM THE MANUAL TROLLEY DUE TO VARIOUS REASONS. AS IT WAS PROVIDED IN THE COMPLAINT RECORD, THE DEVICE INVOLVED WAS A MANUAL TROLLEY, PART NUMBER 6020720171, AND MOST PROBABLY IT WAS MANUFACTURED BEFORE 2011 BY GETINGE. AT THE TIME OF EVENT OCCURRENCE, IT WAS USED TOGETHER WITH ONE OF THE 88-SERIES WASHER DISINFECTORS. NONE OF THE PROVIDED INFORMATION INDICATES THAT UPON THE EVENT OCCURRENCE THE DEVICE WAS BEING USED FOR PATIENT TREATMENT OR DIAGNOSIS. DURING THE INVESTIGATION, IT WAS FOUND THAT THIS COMPLAINT IS THE FIRST CASE WHERE THE REPORTED SCENARIO HAS LED TO SERIOUS INJURY WHEN THE 88-WASHER DISINFECTOR WAS USING. HOWEVER, IT IS THE SECOND EVENT IN WHICH THE SIMILAR SCENARIO HAD LED TO SERIOUS INJURY WITHIN THE LAST 5 YEARS. IT WAS ESTABLISHED THAT WHEN THE EVENT OCCURRED, THE MANUAL TROLLEY, WHICH IS USED AS A SYSTEM WITH WASHER DISINFECTOR 88-5, DID NOT MEET ITS SPECIFICATION AND WAS DIRECTLY INVOLVED IN REPORTED EVENT. WE WERE ALSO ABLE TO ESTABLISH, THAT THE PIN INSTALLED ON THE TROLLEY WAS MISSING AND IT CONSEQUENTLY LED TO THE SITUATION WHERE THE LOAD FELL FROM THE TROLLEY. DUE TO THIS ISSUE THE OPERATOR SUSTAINED FRACTURE OF THE FIFTH TOE OF THE LEFT FOOT. THIS INJURY MADE HER UNABLE TO WORK FOR THREE WEEKS AND SHE GOT A SICK LEAVE FROM WORK UNTIL NOVEMBER 17TH, 2021. A GETINGE SERVICE TECHNICIAN VISITED THE CUSTOMER SITE, RESOLVED THE PROBLEM, RE-INSTALLED THE PIN AND RETURNED THE DEVICE FOR USAGE ¿ IT IS NOW FULLY OPERATIONAL. WE BELIEVE THAT DEVICES IN THE MARKET ARE PERFORMING CORRECTLY OVERALL. GIVEN THE CIRCUMSTANCES WE SHALL CONTINUE TO MONITOR FOR ANY FURTHER EVENTS OF THIS NATURE.
ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION. DEVICE NOT RETURNED TO THE MANUFACTURER.
ON 28TH OCTOBER, 2021 GETINGE BECAME AWARE OF AN EVENT THAT TOOK PLACE ON (B)(6) 2021. THERE WAS AN ISSUE WITH ONE OF THE NON MEDICAL DEVICE - TROLLEY USED TOGETHER WITH THE 88-SERIES WASHER DISINFECTOR. AS IT WAS STATED, THE LOAD FELL OF THE HANDLING TROLLEY DUE TO MISSING REAR SAFETY STOPPER AND RETRACTABLE FINGER DUE TO THE BROKEN BLOCKAGE. IN CONSEQUENCE, THE OPERATOR BROKE A TOE ON HIS RIGHT FOOT AND HAD CONTUSION ON LEG AND SHOULDER. THE INJURY WAS CLASSIFIED AS SERIOUS. THE INFORMATION PROVIDED CONFIRMS THAT THE OPERATOR HAS FROM 3 TO 6 WEEKS BREAK FROM WORK. RECEIVED ACCIDENT REPORT INDICATES THAT THE STAFF MEMBER TOOK THE UNLOADING TROLLEY AND TOOK OUT THE BASE OF THE WASHER-DISINFECTOR. WHEN SHE PULLED IT TOWARDS HER, THE BASE SLIPPED OFF THE MANUAL TROLLEY AND FELL ONTO HER ARM, SHOULDER, HAND AND FIFTH TOE OF THE LEFT FOOT. THE FIFTH TOE OF THE LEFT FOOT WAS FRACTURED. THE BASE FELL ON THE GROUND (IT CONTAINED OPERATING ROOM EQUIPMENT). THE INJURED PERSON HAD SICK LEAVE UNTIL (B)(6) 2021.
MANUFACTURER REFERENCE NUMBER: (B)(4). ON 28TH OCTOBER, 2021 GETINGE BECAME AWARE OF AN EVENT THAT TOOK PLACE ON (B)(6) 2021. THERE WAS AN ISSUE WITH ONE OF THE NON MEDICAL DEVICE - TROLLEY USED TOGETHER WITH THE 88-SERIES WASHER DISINFECTOR. AS IT WAS STATED, THE LOAD FELL OF THE HANDLING TROLLEY DUE TO MISSING REAR SAFETY STOPPER AND RETRACTABLE FINGER DUE TO THE BROKEN BLOCKAGE. IN CONSEQUENCE, THE OPERATOR BROKE A TOE ON HIS RIGHT FOOT AND HAD CONTUSION ON LEG AND SHOULDER. THE INJURY WAS CLASSIFIED AS SERIOUS. THE INFORMATION PROVIDED CONFIRMS THAT THE OPERATOR HAS FROM 3 TO 6 WEEKS BREAK FROM WORK. RECEIVED ACCIDENT REPORT INDICATES THAT THE STAFF MEMBER TOOK THE UNLOADING TROLLEY AND TOOK OUT THE BASE OF THE WASHER-DISINFECTOR. WHEN SHE PULLED IT TOWARDS HER, THE BASE SLIPPED OFF THE MANUAL TROLLEY AND FELL ONTO HER ARM, SHOULDER, HAND AND LEFT FOOT. THE FIFTH TOE OF THE LEFT FOOT WAS FRACTURED. THE BASE FELL ON THE GROUND (IT CONTAINED OPERATING ROOM EQUIPMENT). THE INJURED PERSON HAD SICK LEAVE UNTIL (B)(6) 2021.
MANUFACTURER REFERENCE NUMBER: (B)(4).
ON 28TH OCTOBER, 2021 GETINGE BECAME AWARE OF AN EVENT THAT TOOK PLACE ON (B)(6) 2021. THERE WAS AN ISSUE WITH ONE OF THE NON MEDICAL DEVICE - TROLLEY USED TOGETHER WITH THE 88-SERIES WASHER DISINFECTOR. AS IT WAS STATED, THE LOAD FELL OF THE HANDLING TROLLEY DUE TO MISSING REAR SAFETY STOPPER AND RETRACTABLE FINGER DUE TO THE BROKEN BLOCKAGE. IN CONSEQUENCE, THE OPERATOR BROKE A TOE ON HIS RIGHT FOOT AND HAD CONTUSION ON LEG AND SHOULDER. THE INJURY WAS CLASSIFIED AS SERIOUS. THE INFORMATION PROVIDED CONFIRMS THAT THE OPERATOR HAS FROM 3 TO 6 WEEKS BREAK FROM WORK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1674170 | 88-SERIES | DISINFECTOR, MEDICAL DEVICES | MEC | GETINGE DISINFECTION AB | 88-5 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female | Other |