86-SERIES
Report
- Report Number
- 9616031-2021-00016
- Event Type
- Malfunction
- Date Received
- June 25, 2021
- Date of Event
- June 21, 2021
- Report Date
- August 26, 2021
- Manufacturer
- GETINGE DISINFECTION AB
- Product Code
- MEC
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION THE PURPOSE OF THIS SUBMISSION IS ALSO TO PROVIDE A CORRECTION OF MANUFACTURE DATE. THIS IS BASED ON THE RESULT OF AN INTERNAL REVIEW NOTING THE INITIAL REPORT WAS INCORRECTLY SUBMITTED STATING ANOTHER MANUFACTURE DATE. PREVIOUS MANUFACTURE DATE#: 2019-02-21. CORRECTED MANUFACTURE DATE#: 2019-01-29.
THE PURPOSE OF THIS SUBMISSION IS TO PROVIDE A CORRECTION OF #H10 ADDITIONAL MANUFACTURER NARRATIVE PREVIOUS # H10 ADDITIONAL MANUFACTURER NARRATIVE: WHEN REVIEWING REPORTABLE EVENTS FOR THIS TYPE OF ISSUES WE WERE ABLE TO ESTABLISH THAT THE COMPLAINT IS ONE OF SEVERAL REPORTED WITH AN ALLEGATION ABOUT CART FALLING OR NEARLY FALLING FROM THE MANUAL TROLLEY DUE TO THE VARIOUS REASONS REGISTERED FOR ACCESSORIES USED WITH GETINGE DISINFECTION AB DEVICES REPORTED TO COMPANY¿S COMPLAINT HANDLING SYSTEM WITHIN LAST 5 YEARS. AS IT WAS PROVIDED IN THE COMPLAINT RECORD, THE DEVICE INVOLVED WAS A MANUAL TROLLEY. AT THE TIME OF EVENT OCCURRENCE, IT WAS USED TOGETHER WITH WASHER DISINFECTOR 8668, WITH SERIAL NUMBER (B)(6), CATALOG NUMBER S-86682003-CTOM AND UDI NUMBER (B)(4). THE DEVICE WAS MANUFACTURED ON 29TH JANUARY, 2019 AND INSTALLED IN THE FACILITY ON 27TH FEBRUARY 2020. THE WASHER DISINFECTOR IS UNDER WARRANTY. LAST PREVENTIVE MAINTENANCE WAS DONE ON 9TH MARCH, 2021. NONE OF THE PROVIDED INFORMATION INDICATES THAT UPON THE EVENT OCCURRENCE THE DEVICE WAS BEING USED FOR PATIENT TREATMENT. DURING THE INVESTIGATION, IT WAS FOUND THAT IN THE PAST THE REPORTED SCENARIO HAS NEVER LEAD TO SERIOUS INJURY OR WORSE, TO DEATH. IT WAS ESTABLISHED THAT WHEN THE EVENT OCCURRED, THE TROLLEY, WHICH IS USED, WITH WASHER DISINFECTOR 8668 DID NOT MEET ITS SPECIFICATION. DURING THE INVESTIGATION COURSE WE WERE ABLE TO ESTABLISH, THAT THE PIN INSTALLED ON THE TROLLEY WAS NOT WORKING AS INTENDED AND THE CONSEQUENTLY LED TO THE SITUATION WHEN THE CART ALMOST FELL OFF AND ONTO THE GROUND. A GETINGE SERVICE TECHNICIAN VISITED THE CUSTOMER SITE, RESOLVED THE PROBLEM, REPLACED THE PIN AND RETURNED THE DEVICE FOR USAGE IN FULLY OPERATIONAL STAGE. WE BELIEVE THAT DEVICES IN THE MARKET ARE PERFORMING CORRECTLY OVERALL. GIVEN THE CIRCUMSTANCES AND THE FACT THAT THERE IS NO APPARENT TREND IN COMPLAINTS OF THIS NATURE, WE SHALL CONTINUE TO MONITOR FOR ANY FURTHER EVENTS OF THIS NATURE. CORRECTED #H10 ADDITIONAL MANUFACTURER NARRATIVE WHEN REVIEWING REPORTABLE EVENTS FOR THIS TYPE OF ISSUES WE WERE ABLE TO ESTABLISH THAT THE COMPLAINT IS ONE OF SEVERAL REPORTED WITH AN ALLEGATION ABOUT CART FALLING OR NEARLY FALLING FROM THE MANUAL TROLLEY DUE TO THE VARIOUS REASONS REGISTERED FOR ACCESSORIES USED WITH GETINGE DISINFECTION AB DEVICES REPORTED TO COMPANY¿S COMPLAINT HANDLING SYSTEM WITHIN LAST 5 YEARS. AS IT WAS PROVIDED IN THE COMPLAINT RECORD, THE DEVICE INVOLVED WAS A MANUAL TROLLEY. AT THE TIME OF EVENT OCCURRENCE, IT WAS USED TOGETHER WITH WASHER DISINFECTOR 8668, WITH SERIAL NUMBER (B)(6), CATALOG NUMBER S-86682003-CTOM AND UDI NUMBER (B)(4). THE DEVICE WAS MANUFACTURED ON 29TH JANUARY, 2019 AND INSTALLED IN THE FACILITY ON 27TH FEBRUARY 2020. WHEN THE EVENT OCCURRED THE WASHER DISINFECTOR WAS UNDER WARRANTY AND THE LAST PREVENTIVE MAINTENANCE WAS DONE ON 9TH MARCH, 2021. NONE OF THE PROVIDED INFORMATION INDICATES THAT UPON THE EVENT OCCURRENCE THE DEVICE WAS BEING USED FOR PATIENT TREATMENT. DURING THE INVESTIGATION IT WAS FOUND THAT IN THE PAST THE REPORTED SCENARIO HAS LEAD TO SERIOUS INJURY. IT WAS ESTABLISHED THAT WHEN THE EVENT OCCURRED, THE TROLLEY, WHICH IS USED, WITH WASHER DISINFECTOR 8668 DID NOT MEET ITS SPECIFICATION. DURING THE INVESTIGATION COURSE WE WERE ABLE TO ESTABLISH, THAT THE PIN INSTALLED ON THE TROLLEY WAS NOT WORKING AS INTENDED AND THE CONSEQUENTLY LED TO THE SITUATION WHEN THE CART ALMOST FELL OFF AND ONTO THE GROUND. A GETINGE SERVICE TECHNICIAN VISITED THE CUSTOMER SITE, RESOLVED THE PROBLEM, REPLACED THE PIN AND RETURNED THE DEVICE FOR USAGE IN FULLY OPERATIONAL STAGE. WE BELIEVE THAT DEVICES IN THE MARKET ARE PERFORMING CORRECTLY OVERALL. GIVEN THE CIRCUMSTANCES AND THE FACT THAT THERE IS NO APPARENT TREND IN COMPLAINTS OF THIS NATURE, WE SHALL CONTINUE TO MONITOR FOR ANY FURTHER EVENTS OF THIS NATURE.
WHEN REVIEWING REPORTABLE EVENTS FOR THIS TYPE OF ISSUES WE WERE ABLE TO ESTABLISH THAT THE COMPLAINT IS ONE OF SEVERAL REPORTED WITH AN ALLEGATION ABOUT CART FALLING OR NEARLY FALLING FROM THE MANUAL TROLLEY DUE TO THE VARIOUS REASONS REGISTERED FOR ACCESSORIES USED WITH GETINGE DISINFECTION AB DEVICES REPORTED TO COMPANY¿S COMPLAINT HANDLING SYSTEM WITHIN LAST 5 YEARS. AS IT WAS PROVIDED IN THE COMPLAINT RECORD, THE DEVICE INVOLVED WAS A MANUAL TROLLEY. AT THE TIME OF EVENT OCCURRENCE, IT WAS USED TOGETHER WITH WASHER DISINFECTOR 8668, WITH SERIAL NUMBER (B)(6), CATALOG NUMBER S-86682003-CTOM AND UDI NUMBER (B)(4). THE DEVICE WAS MANUFACTURED ON 29TH JANUARY, 2019 AND INSTALLED IN THE FACILITY ON 27TH FEBRUARY 2020. THE WASHER DISINFECTOR IS UNDER WARRANTY. LAST PREVENTIVE MAINTENANCE WAS DONE ON 9TH MARCH, 2021. NONE OF THE PROVIDED INFORMATION INDICATES THAT UPON THE EVENT OCCURRENCE THE DEVICE WAS BEING USED FOR PATIENT TREATMENT. DURING THE INVESTIGATION, IT WAS FOUND THAT IN THE PAST THE REPORTED SCENARIO HAS NEVER LEAD TO SERIOUS INJURY OR WORSE, TO DEATH. IT WAS ESTABLISHED THAT WHEN THE EVENT OCCURRED, THE TROLLEY, WHICH IS USED, WITH WASHER DISINFECTOR 8668 DID NOT MEET ITS SPECIFICATION. DURING THE INVESTIGATION COURSE WE WERE ABLE TO ESTABLISH, THAT THE PIN INSTALLED ON THE TROLLEY WAS NOT WORKING AS INTENDED AND THE CONSEQUENTLY LED TO THE SITUATION WHEN THE CART ALMOST FELL OFF AND ONTO THE GROUND. A GETINGE SERVICE TECHNICIAN VISITED THE CUSTOMER SITE, RESOLVED THE PROBLEM, REPLACED THE PIN AND RETURNED THE DEVICE FOR USAGE IN FULLY OPERATIONAL STAGE. WE BELIEVE THAT DEVICES IN THE MARKET ARE PERFORMING CORRECTLY OVERALL. GIVEN THE CIRCUMSTANCES AND THE FACT THAT THERE IS NO APPARENT TREND IN COMPLAINTS OF THIS NATURE, WE SHALL CONTINUE TO MONITOR FOR ANY FURTHER EVENTS OF THIS NATURE.
MANUFACTURER REFERENCE NUMBER: (B)(4).
MANUFACTURER REFERENCE NUMBER: (B)(4).
MANUFACTURER REFERENCE NUMBER: (B)(4).
ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION. DEVICE NOT RETURNED TO THE MANUFACTURER.
ON 21ST OF JUNE GETINGE RECEIVED THE INFORMATION THAT THE STOP PIN WAS MISSING ON THE TRANSFER TROLLEY USED AS AN ACCESSORY TO THE 8668 WASHER DISINFECTOR. AS IT WAS STATED DUE TO THIS MISSING PART THE RACK TRANSPORTED ON THIS TROLLEY NEARLY FELL OF THE GROUND. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY RACK FALLING ON THE FLOOR COULD CAUSE THE INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 962275 | 86-SERIES | DISINFECTOR, MEDICAL DEVICES | MEC | GETINGE DISINFECTION AB | 8668 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |