8668
Report
- Report Number
- 9616031-2019-00011
- Event Type
- Malfunction
- Date Received
- April 1, 2019
- Report Date
- July 10, 2019
- Manufacturer
- GETINGE DISINFECTION AB
- Product Code
- MEC
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- 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 (B)(6) (REGISTRATION NO. (B)(4). THE ISSUE IS STILL 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 STILL BEING INVESTIGATED BY MANUFACTURING SITE.
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 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 LOGISTIC AMERICA, LLC (REGISTRATION NO. 3012092534). THE ISSUE IS BEING INVESTIGATED BY MANUFACTURING SITE.
THE ISSUE IS STILL BEING INVESTIGATED BY MANUFACTURING SITE.
MANUFACTURER REFERENCE NUMBER: (B)(4).
MANUFACTURER REFERENCE NUMBER: (B)(4).
MANUFACTURER REFERENCE NUMBER: (B)(4).
ON (B)(4) 2019 GETINGE DISINFECTION (B)(4) BECAME AWARE OF AN ISSUE WITH ONE OF THE WASHER DISINFECTOR- 8666 MODEL NUMBER. AS IT WAS STATED, DURING THE CYCLE LUBRICANT WAS DISPENSED INSTEAD OF THE DETERGENT. NONE OF INFORMATION RECEIVED SUGGEST THAT AN INJURY OCCURRED. WITH THE LIMITED INFORMATION AVAILABLE, WE WERE NOT ABLE TO ESTABLISH UNDER WHAT CIRCUMSTANCES THE CUSTOMER BECAME AWARE OF THE PROBLEM NOR IF THE LOAD WAS REPROCESSED. GETINGE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL AS AN INCORRECT CHEMICAL DOSING MIGHT LEAD TO UNDETECTED FAILURE WITH THE CLEANING AND DISINFECTION OF THE LOADS AND CONSEQUENTLY TO AN ADVERSE EVENT. (B)(4).
MANUFACTURER REFERENCE NUMBER: (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 263150 | 8668 | DISINFECTOR, MEDICAL DEVICES | MEC | GETINGE DISINFECTION AB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |