FSC
Report
- Report Number
- 9616031-2019-00008
- Event Type
- Malfunction
- Date Received
- March 18, 2019
- Date of Event
- June 30, 2018
- Report Date
- May 27, 2019
- Manufacturer
- GETINGE DISINFECTION AB
- Product Code
- PEC
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- 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 LOGISTICS AMERICA, LLC (REGISTRATION NO. 3012092534). THE IMPORTER REPORT NUMBER WAS INCORRECTLY ASSIGNED TO THE RECORD, THEREFORE WE ARE SENDING THE FOLLOW UP REPORT WITH THE CORRECT NUMBER ASSIGNED. IT HAS BEEN CLARIFIED BY THE CUSTOMER THAT HE HAS 88-5 WASHER-DISINFECTOR DEVICES IN THE DEPARTMENT, HOWEVER THE FSC INVOLVED IN THIS EVENT IS USED AS AN INDEPENDENT DEVICE, NOT DIRECTLY CONNECTED TO THE WASHER-DISINFECTORS. NEVERTHELESS, WE ARE STILL SEEING THIS SETUP AS A SYSTEM AND REPORTING AS SUCH.
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. (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 A FIFTH ONE WHERE THE CART FELL OFF FROM THE FSC DEVICE. IT HAS BEEN CLARIFIED BY THE CUSTOMER THAT HE HAS 88-5 WASHER-DISINFECTOR DEVICES IN THE DEPARTMENT, HOWEVER THE FSC INVOLVED IN THIS EVENT IS USED AS AN INDEPENDENT DEVICE, NOT DIRECTLY CONNECTED TO THE WASHER-DISINFECTORS. NEVERTHELESS, WE ARE STILL SEEING THIS SETUP AS A SYSTEM AND REPORTING AS SUCH. THE SERIAL NUMBER OF THE ACCESSORY WAS (B)(4). THE UNIT WAS MANUFACTURED ON 19TH OCTOBER, 2011. INSTALLATION DATE IS 6TH DECEMBER, 2012. AS IT WAS STATED, THE CARTS WERE FALLING OFF FROM THE DEVICE. THERE WAS NO INJURY REPORTED HOWEVER WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL AS CARTS FALLING OFF MAY LEAD TO AN ADVERSE EVENT. 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. UNFORTUNATELY, IT IS IMPOSSIBLE TO ESTABLISH THE MAIN FACTOR WHICH LED TO THE ISSUE OCCURRENCE. THE MOST LIKELY SCENARIO IS THAT THE CONVEYOR WAS WRONGLY LOADED BY THE USER, HOWEVER IT CANNOT BE FULLY CONFIRMED. THE DEVICE IS UNDER GETINGE PREVENTIVE MAINTENANCE AND DURING LAST THREE SERVICES THE DEVICE WAS INSPECTED AND REPAIRED, IF NEEDED. WE BELIEVE THAT CURRENTLY AND OVERALL, THE RELATED DEVICES ARE PERFORMING CORRECTLY IN THE MARKET WITH REGARDS TO THE REPORTED ISSUE.
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. WE ARE AWARE THAT THIS IS PAST THE 30 DAY DEADLINE FOR REPORTING. WE HAVE REMINDED THE COMPLAINT HANDLER TO REVIEW FDA REPORTING GUIDELINES IN ORDER TO PREVENT THIS FROM HAPPENING AGAIN.
MANUFACTURER REFERENCE NUMBER # (B)(4).
MANUFACTURER REFERENCE NUMBER # (B)(4).
MANUFACTURER REFERENCE NUMBER # (B)(4).
MANUFACTURER REFERENCE NUMBER #: (B)(4).
ON (B)(6) 2018 WE BECAME AWARE OF AN ISSUE WITH FSC - LOADING EQUIPMENT. THE DEVICE WAS USED TOGETHER WITH THE MEDICAL DEVICE AS A SYSTEM. AS IT WAS STATED, THE CARTS WERE FALLING OFF FROM THE DEVICE. THERE WAS NO INJURY REPORTED; HOWEVER, WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL AS CARTS FALLING OFF MAY LEAD TO AN ADVERSE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 220715 | FSC | STERILIZER AUTOMATED LOADING SYSTEM | PEC | GETINGE DISINFECTION AB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |