86-SERIES
Report
- Report Number
- 9616031-2019-00002
- Event Type
- Malfunction
- Date Received
- January 28, 2019
- Date of Event
- January 21, 2019
- Report Date
- January 23, 2020
- Manufacturer
- GETINGE DISINFECTION AB
- Product Code
- MEC
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, 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 LOGISTICS 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. 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). THE ISSUE IS STILL BEING INVESTIGATED BY MANUFACTURING SITE.
THE ISSUE IS STILL BEING INVESTIGATED BY MANUFACTURING SITE.
GETINGE BECAME AWARE ABOUT AN INCIDENT WITH ONE OF THE WASHER DISINFECTOR- 8668 MODEL NUMBER. AS STATED BY TECHNICIAN WHO VISITED THE FACILITY, SIGNIFICANT OVERHEATING OCCURRED ON THE CONTROL BOX OF THE DEVICE. BASED ON THE INFORMATION COLLECTED TO DATE IT WAS ESTABLISHED THAT THE ISSUE STARTED FROM THE CONTROL BOX OF THE DEVICE. A BLACK SMOKE IS SAID TO HAVE FILLED THE ROOM AND SET THE SPRINKLER SYSTEM OFF. ACCORDING TO INFORMATION PROVIDED BY THE CUSTOMER, THE DEVICE AND INSTRUMENTS INSIDE WERE DAMAGED AS WELL AS WALLS AND CEILING WITHIN THE DECONTAMINATION SIDE OF THE WASHER. THERE WAS NO INJURY REPORTED HOWEVER WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL AS SIGNIFICANT OVERHEATING OF THE DEVICE 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. IN THE TIME WHEN THE EVENT OCCURRED THE DEVICE WAS NOT BEING USED FOR THE PATIENT TREATMENT. DURING THE INVESTIGATION IT WAS FOUND THAT THERE IS NO APPARENT TREND WITH THE ISSUE AT HAND AND THAT THE REPORTED SCENARIO HAS TO DATE NEVER LEAD TO SERIOUS INJURY OR WORSE. FURTHERMORE, IT WAS FOUND THAT THE MOST LIKELY ROOT CAUSE OF THIS EVENT ARE IS RELATED TO THE TOWEL THAT THE TECHNICIAN LEFT ON TOP OF THE DEVICE, BELOW THE CCU, TO WIPE UP THE WATER THAT WAS LEAKING FROM THE CCU. WE BELIEVE THE RELATED DEVICES ARE PERFORMING CORRECTLY IN THE MARKET. WE ALSO BELIEVE THAT IF THE MANUFACTURER RECOMMENDATION WOULD HAVE BEEN FOLLOWED THE INCIDENT WOULD HAVE BEEN AVOIDED.
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.
THE ISSUE IS STILL BEING INVESTIGATED BY MANUFACTURING SITE.
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.
THE ISSUE IS BEING INVESTIGATED BY MANUFACTURING SITE.
THE ISSUE IS BEING INVESTIGATED BY MANUFACTURING SITE.
THE ISSUE IS STILL BEING INVESTIGATED BY MANUFACTURING SITE.
ON (B)(6) 2019 WE BECAME AWARE OF AN ISSUE WITH 86- SERIES WASHER DISINFECTOR DEVICE. AS STATED BY TECHNICIAN WHO VISITED THE FACILITY, SIGNIFICANT OVERHEATING OCCURRED ON THE CONTROL BOX OF THE DEVICE. THERE WAS NO INJURY REPORTED HOWEVER WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL AS SIGNIFICANT OVERHEATING OF THE DEVICE MAY LEAD TO AN ADVERSE EVENT.
THE ISSUE IS STILL BEING INVESTIGATED BY MANUFACTURING SITE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 75595 | 86-SERIES | 8668 | MEC | GETINGE DISINFECTION AB | 8668 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |