FSC
Report
- Report Number
- 9616031-2019-00006
- Event Type
- Malfunction
- Date Received
- March 1, 2019
- Report Date
- May 28, 2019
- Manufacturer
- GETINGE DISINFECTION AB
- Product Code
- PEC
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SW
- Reporter Occupation
- OTHER
Narratives
THIS REPORTS IS BEING FILED UNDER EXEMPTION E2017050 BY THE MANUFACTURER GETINGE DISINFECTION AB (REGISTRATION NO. (B)(4) ON BEHALF OF THE IMPORTER GETINGE GROUP LOGISTIC AMERICA, LLC (REGISTRATION NO. (B)(4). THE ISSUE IS BEING INVESTIGATED BY MANUFACTURING SITE.
THIS REPORTS IS BEING FILED UNDER EXEMPTION E2017050 BY THE MANUFACTURER GETINGE DISINFECTION AB (REGISTRATION NO. 9616031) ON BEHALF OF THE IMPORTER GETINGE GROUP LOGISTIC AMERICA, LLC (REGISTRATION NO. 3012092534). THE ISSUE IS BEING INVESTIGATED BY MANUFACTURING SITE.
THIS REPORTS IS BEING FILED UNDER EXEMPTION E2017050 BY THE MANUFACTURER GETINGE DISINFECTION AB (REGISTRATION NO. 9616031) ON BEHALF OF THE IMPORTER GETINGE GROUP LOGISTIC AMERICA, LLC (REGISTRATION NO. 3012092534). THE ISSUE IS BEING INVESTIGATED BY MANUFACTURING SITE.
THIS REPORT IS BEING FILED UNDER EXEMPTION E2017050 BY THE MANUFACTURER GETINGE DISINFECTION AB, (REGISTRATION NO. (B)(4)) ON BEHALF OF THE IMPORTER GETINGE GROUP LOGISTICS AMERICA, LLC (REGISTRATION NO. (B)(4)). WHEN REVIEWING REPORTABLE EVENTS, WE WERE ABLE TO ESTABLISH THAT THIS ISSUE IS THE 12TH REPORTABLE COMPLAINT WHERE CART FELL OFF FROM THE LOADING EQUIPMENT OUTSIDE WASHER DISINFECTOR SUCH AS AIR GLIDE SYSTEM (AGS), FREE STANDING CONVEYOR (FSC) AND RETURN CONVEYOR (RC). THE GETINGE RC LOADING EQUIPMENT IS NOT REGISTERED AS A MEDICAL DEVICE ITSELF BUT SINCE UPON ISSUE OCCURRENCE, IT WAS USED TOGETHER WITH USED WITH 86-SERIES WASHER-DISINFECTOR, WE DECIDED TO REPORT THE COMPLAINT TO COMPETENT AUTHORITIES IN REGARD TO THE SYSTEM. THE SERIAL NUMBER OF THE ACCESSORY WAS (B)(4). THE UNIT WAS MANUFACTURED ON 13TH FEBRUARY, 2017 AND INSTALLED ON 1ST JULY 2017. THE WASHER SERIAL NUMBER THE LOADING EQUIPMENT WAS USED WITH HAS NOT BEEN PROVIDED. AS EXPLAINED BY THE CUSTOMER, THE END PIN ON THE CONVEYOR WAS STUCK IN "IN-POSITION" RESULTING IN A SITUATION WHEN A TROLLEY DETACHED FROM IT. FORTUNATELY, THE USER NOTICED THE SITUATION AND WAS ABLE TO STOP A FALLING TROLLEY BEFORE IT TOUCHED THE GROUND. NO INJURIES WERE REPORTED IN RELATION TO THIS EVENT. NEVERTHELESS, WE DECIDED TO REPORT THIS COMPLAINT BASED ON THE POTENTIAL FOR ADVERSE EVENT IF IT WAS TO REOCCUR. AFTER INCIDENT OCCURRED, THE ACCESSORY HAS BEEN INSPECTED BY GETINGE TECHNICIAN. IT WAS FOUND THAT ONE OF THE SCREWS FROM DOCKING PIN WAS TOO LONG AND REQUIRED INTERVENTION: TWO DISCS WERE ADDED AND LOCTITE WAS APPLIED ON IT TO PREVENT THE BOLT FROM SLIPPING, WHICH BLOCKED THE END PIN. THE DEVICE WAS RETURNED FOR USAGE BY CUSTOMER AFTERWARDS. THE ISSUE WAS INVESTIGATED BY MANUFACTURING SITE. IT WAS STATED THAT IN CASE OF LOCKING END STOP PIN IN DOWN POSITION, RC WILL STOP AND THE RESET BUTTON WILL INDICATE AN ERROR WITH THE CONVEYOR. IN THE SITUATION DESCRIBED USER IS TO CALL FOR TECHNICIAN SUPPORT. BASED ON PERFORMED INVESTIGATION, IT HAS BEEN DEFINED THAT FOR THIS DEVICE UNIT, THE SCENARIO OF CART FALLING OFF FROM THE RC IS RELATED TO THE USER NOT FOLLOWING INSTRUCTIONS IN SITUATION WHEN ERROR OCCUR ON THE UNIT. IT WAS STATED THAT OPERATOR RESET THE ERROR BY THEMSELVES AND THIS CONTRIBUTED TO THE EVENT. IN SUMMARY, WHEN THE EVENT OCCURRED, THE DEVICE PLAYED A ROLE IN THE EVENT AND DID NOT MEET ITS SPECIFICATION. IN THE TIME WHEN THE EVENT OCCURRED, THE ACCESSORY WAS NOT BEING USED FOR PATIENT TREATMENT. GIVEN THE FINDINGS OF THIS INVESTIGATION GETINGE SHALL CONTINUE TO MONITOR FOR ANY FURTHER EVENTS OF THIS NATURE AND DOES NOT PROPOSE ANY OTHER ACTION AT THIS TIME.
THIS REPORT IS BEING FILED UNDER EXEMPTION E2017050 BY THE MANUFACTURER GETINGE DISINFECTION AB, (REGISTRATION NO. 9616031) ON BEHALF OF THE IMPORTER GETINGE GROUP LOGISTICS AMERICA, LLC (REGISTRATION NO. 3012092534). THE ISSUE IS BEING INVESTIGATED BY MANUFACTURING SITE.
ON (B)(6) 2019 WE BECAME AWARE OF AN ISSUE WITH A LOADING EQUIPMENT OUTSIDE THE MACHINE - FSC (FREE STANDING CONVEYOR). AS IT WAS STATED, THE END PIN ON THE CONVEYOR WAS STUCK IN "IN-POSITION" RESULTING IN A SITUATION WHEN A TROLLEY DETACHED FROM IT. FORTUNATELY, THE USER NOTICED THE SITUATION AND WAS ABLE TO STOP A FALLING TROLLEY BEFORE IT TOUCHED THE GROUND. NO INJURIES WERE REPORTED IN RELATION TO THIS EVENT. NEVERTHELESS, WE DECIDED TO REPORT THIS COMPLAINT BASED ON THE POTENTIAL FOR ADVERSE EVENT IF IT WAS TO REOCCUR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 175531 | FSC | FSC | PEC | GETINGE DISINFECTION AB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |