AGS
Report
- Report Number
- 9616031-2019-00007
- Event Type
- Malfunction
- Date Received
- March 14, 2019
- Report Date
- May 27, 2019
- Manufacturer
- GETINGE DISINFECTION AB
- Product Code
- PEC
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SN
- 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). 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. 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). WHEN REVIEWING REPORTABLE EVENTS, WE WERE ABLE TO ESTABLISH THAT THIS ISSUE IS A FOURTH ONE WHERE THE CART FELL OR ALMOST FELL OFF FROM THE AIR GLIDE SYSTEM (AGS) LOADING SYSTEM. THE GETINGE AGS LOADING EQUIPMENT IS NOT REGISTERED AS A MEDICAL DEVICE ITSELF BUT SINCE UPON ISSUE OCCURRENCE, IT WAS USED TOGETHER WITH A 8668 WASHER-DISINFECTOR, WE DECIDED TO REPORT THE COMPLAINT TO COMPETENT AUTHORITIES WITH REGARDS TO THE SYSTEM. THE SERIAL NUMBER OF THE ACCESSORY WAS (B)(4). THE UNIT WAS MANUFACTURED ON 21ST JUNE, 2007. AS IT WAS STATED, THE END STOP WAS JAMMED INTERMITTENTLY WHICH NEARLY CAUSED THE WASH CART TO FALL OVER. THERE WAS NO INJURY REPORTED HOWEVER WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL AS FALLING CART 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. THE ISSUE WAS FOUND MOST LIKELY RELATED TO LACK OF MAINTENANCE OF THE DEVICE INVOLVED, AS THE END STOP PIN COULD WEAR AND TEAR OVER THE LIFE TIME (THE LIFETIME OF THE INVOLVED UNIT WAS ESTABLISHED TO BE 11 YEARS) IN PARTICULAR SINCE INDICATION OF REGULAR MAINTENANCE PER PREVENTIVE MAINTENANCE INSTRUCTIONS IS ABSENT. PROVIDED SERVICE HISTORY RECORDS FOR PREVENTIVE MAINTENANCE BY GETINGE SALES AND SERVICE UNITS PROVE ONLY THAT THE DEVICE WAS OPERATING CORRECTLY AFTER THE ISSUE WAS NOTICED, AS BOTH OF THE PREVENTIVE MAINTENANCES ON THIS PART THAT ARE KNOWN TO US WERE PERFORMED AFTER THE ISSUE OCCURRENCE. 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.(B)(4)) ON BEHALF OF THE IMPORTER GETINGE GROUP LOGISTICS AMERICA, LLC (REGISTRATION NO. (B)(4)). THE ISSUE IS STILL BEING INVESTIGATED BY MANUFACTURING SITE.
ON (B)(6)2018 WE BECAME AWARE OF AN ISSUE WITH AGS- LOADING EQUIPMENT OUTSIDE MACHINE WHICH WAS USED TOGETHER WITH 8666 WASHER DISINFECTOR. AS IT WAS STATED, THE END STOP WAS JAMMED INTERMITTENTLY WHICH NEARLY CAUSED THE WASH CART TO FALL OVER. THERE WAS NO INJURY REPORTED HOWEVER WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL AS FALLING CART MAY LEAD TO AN ADVERSE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 215852 | AGS | AGS | PEC | GETINGE DISINFECTION AB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |