AGS
Report
- Report Number
- 9616031-2018-00008
- Event Type
- Malfunction
- Date Received
- August 13, 2018
- Date of Event
- July 25, 2018
- Report Date
- November 6, 2018
- Manufacturer
- GETINGE DISINFECTION AB
- Product Code
- MEC
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER
Narratives
THIS REPORT 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). ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION.
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 STILL BEING INVESTIGATED BY MANUFACTURING SITE.
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 STILL BEING INVESTIGATED BY MANUFACTURING SITE.
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). GETINGE BECAME AWARE OF AN INCIDENT WITH ONE OF OUR DEVICE- AGS. THE CART DID NOT STOP AT THE END OF THE UNLOADER AND AS A RESULT IT FELL DOWN TOGETHER WITH ALL INSTRUMENTS PLACED IN THE CART. NO INJURY HAS BEEN REPORTED. THE DEVICE INVOLVED IN THE EVENT IS AGS WITH SERIAL NUMBER (B)(4). THE DEVICE WAS INSTALLED ON 28TH JANUARY, 2016 AND MANUFACTURED ON 3RD JUNE, 2015. THE TECHNICIAN WHO EVALUATED THE DEVICE PERFORMED MULTIPLE TESTS AND UNIT OPERATED AS IT SHOULD. HE WAS NEVER ABLE TO DUPLICATE THE ISSUE. THE UNIT WAS FOUND TO BE OPERATIONAL AND FUNCTIONAL. THERE WAS A FIELD ACTION LAUNCHED TO UPDATE THE DEVICES ON THE MARKET TO ADDRESS THIS ISSUE. THE ISSUE IS BEING ADDRESSED WITH FIELD ACTION Z-1379-2018 AND Z-1380-2018 ON US MARKET. THE DEVICE INVOLVED IN THIS INCIDENT WAS UPDATED AS PER FIELD ACTION INSTRUCTION BEFORE THE ISSUE OCCURRED. HOWEVER IT APPEARS THAT DUE TO A FAULTY INSTALL THE PROBLEM WAS NOT ALLEVIATED ON THIS DEVICE. DURING THE INVESTIGATION IT WAS FOUND THAT THE ISSUE INVESTIGATED HEREIN IS A SINGLE ISOLATED EVENT. REVIEW BY THE PRODUCT SPECIALISTS AT THE MANUFACTURER OF THE PARTICULARITIES OF THIS EVENT AND THE FACT THE FAILURE COULD NOT BE REPRODUCED, RESULTS TO CONCLUDE THAT THE ISSUE IS NOT EXPECTED TO RE-OCCUR WITH DEVICES ALREADY ADDRESSED AND THAT THIS WILL REMAIN AN ISOLATED EVENT. GETINGE RELEASED NEW INSTRUCTIONS HOW TO MAKE AN UPDATE ON 24TH AUGUST, 2018. IT WAS ESTABLISHED THAT WHEN THE EVENT OCCURRED, THE DEVICE DID NOT MEET ITS SPECIFICATION AND IT CONTRIBUTED TO EVENT. UPON THE EVENT OCCURRENCE THE DEVICE WAS NOT BEING USED FOR PATIENT TREATMENT.
ON (B)(6) 2018 GETINGE BECAME AWARE OF AN INCIDENT WITH ONE OF OUR DEVICE. AS IT WAS STATED BY THE CUSTOMER AFTER THE END OF THE CYCLE THE CART FROM WASHER DISINFECTOR WAS TRANSFERRED BY THE AUTOMATIC UNLOADER TO THE CLEAN SIDE. AS NORMALLY THE CART SHOULD STOPPED AT THE END OF THE UNLOADER BUT IT DID NOT HAPPEN. THE CART DID NOT STOP WHEN REACHED END OF THE UNLOADER AND AS A RESULT IT FELL DOWN WITH ALL INSTRUMENTS PLACED ON THE CART. NO INJURY HAS BEEN REPORTED, HOWEVER WE DECIDED TO REPORT IT IN ABUNDANCE OF CAUTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 620399 | AGS | MEC | MEC | GETINGE DISINFECTION AB | AGS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |