800-SERIES
Report
- Report Number
- 3012068831-2019-00010
- Event Type
- Malfunction
- Date Received
- August 21, 2019
- Report Date
- March 4, 2020
- Manufacturer
- GETINGE IC PRODUCTION POLAND SP. Z O.O.
- Product Code
- FLE
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
THE ISSUE IS STILL BEING INVESTIGATED BY MANUFACTURING SITE.
THE ISSUE IS STILL BEING INVESTIGATED BY MANUFACTURING SITE.
GETINGE BECAME INFORMED OF AN ISSUE WITH A STEAM STERILIZER 833HC DEVICE WITH SERIAL NUMBER: (B)(6). THE ISSUE WAS DESCRIBED BY THE CUSTOMER AS FOLLOWS: LARGE AMOUNT OF STEAM LEAKED FROM THE TOP OF THE DEVICE DOOR. THERE WASN'T ANY INJURY REPORTED DUE TO THIS CASE, HOWEVER WE DECIDED TO REPORT THIS CASE IN ABUNDANCE OF CAUTION AS ANY UNEXPECTED STEAM LEAK UNDER THE PRESSURE AND FROM PARTS FACING THE CUSTOMER MIGHT LEAD TO AN ADVERSE EVENT. IT WAS DECIDED TO REPORT THIS ISSUE BASED ON THE POTENTIAL RELATED TO WORST CASE SCENARIO. WHEN REVIEWING REPORTABLE EVENTS FOR THIS TYPE OF ISSUES WE WERE ABLE TO FIND SEVERAL SIMILAR COMPLAINTS WHERE THE STEAM HAS BLOWN FROM THE DOOR AREA FOR VARIOUS REASONS. FORTUNATELY THE EVENT HAS NOT LED TO SERIOUS INJURY OR WORSE. THE 2005 DEVICE RECEIVED PREVENTIVE MAINTENANCE PERFORMED ON MAY, 2019. WHEN THE EVENT OCCURRED, THE DEVICE DID NOT MEET ITS SPECIFICATION AND IT CONTRIBUTED TO EVENT. THE PROVIDED INFORMATION DID NOT INDICATE THAT THE DEVICE WAS BEING USED FOR PATIENT TREATMENT WHEN THE EVENT TOOK PLACE. BASED ON PERFORMED ROOT CAUSE ANALYSIS WE CONCLUDE THAT THE STEAM BLOWING FROM DOOR OF THE STERILIZER DEVICE WAS CAUSED BY A FAULTY DOOR GASKET. IT APPEARS THE MOST LIKELY CAUSE FOR THE EVENT RELATES TO THE DOOR GASKET HAVING BECOME DAMAGED DURING USE. WE CURRENTLY DO NOT HAVE ANY INFORMATION THAT WOULD WARRANT FURTHER ACTION TOWARDS THE DEVICE MANUFACTURING OR DEVICES ON THE MARKET, HOWEVER AS PER OUR COMPLAINT HANDLING PROCESSES WILL CONTINUE TO MONITOR THE CUSTOMER EXPERIENCES WITH THE DEVICE FOR ANY FUTURE INFORMATION. CORRECTED DATA: THE PURPOSE OF THIS SUBMISSION IS SOLELY TO PROVIDE A CORRECTION OF MODEL NAME INCLUDED IN DESCRIBE EVENT OR PROBLEM AND VERSION OR MODEL#: SECTIONS. THIS IS BASED ON THE RESULT OF AN INTERNAL REVIEW NOTING THE REPORT WAS INCORRECTLY SUBMITTED STATING ANOTHER MODEL NAME. #B5: PREVIOUS DESCRIBE EVENT OR PROBLEM: ON 9TH JULY, 2019, GETINGE BECAME AWARE ABOUT AN ISSUE WITH ONE OF THE STEAM STERILIZER- 833 HC-E. AS IT WAS STATED, LARGE AMOUNT OF STEAM LEAKED FROM THE TOP OF THE DEVICE DOOR. THERE WAS NO INJURY REPORTED, HOWEVER IT WAS DECIDED TO REPORT THIS ISSUE BASED ON THE POTENTIAL, AS ANY UNEXPECTED STEAM LEAK FROM PARTS AVAILABLE FOR THE CUSTOMER MIGHT LED TO AN ADVERSE EVENT. CORRECTED DESCRIBE EVENT OR PROBLEM: ON 9TH JULY, 2019, GETINGE BECAME AWARE ABOUT AN ISSUE WITH ONE OF THE STEAM STERILIZER- 833 HC. AS IT WAS STATED, LARGE AMOUNT OF STEAM LEAKED FROM THE TOP OF THE DEVICE DOOR. THERE WAS NO INJURY REPORTED, HOWEVER IT WAS DECIDED TO REPORT THIS ISSUE BASED ON THE POTENTIAL, AS ANY UNEXPECTED STEAM LEAK FROM PARTS AVAILABLE FOR THE CUSTOMER MIGHT LED TO AN ADVERSE EVENT. #D4: PREVIOUS VERSION OR MODEL#: 833HC-E. CORRECTED VERSION OR MODEL#: 833HC.
THE ISSUE IS BEING INVESTIGATED BY THE MANUFACTURING SITE.
THE ISSUE IS STILL BEING INVESTIGATED BY MANUFACTURING SITE.
MANUFACTURER'S REFERENCE NUMBER (B)(4).
MANUFACTURER'S REFERENCE NUMBER: (B)(4).
ON 9TH JULY, 2019, GETINGE BECAME AWARE ABOUT AN ISSUE WITH ONE OF THE STEAM STERILIZER- 833 HC. AS IT WAS STATED, LARGE AMOUNT OF STEAM LEAKED FROM THE TOP OF THE DEVICE DOOR. THERE WAS NO INJURY REPORTED, HOWEVER IT WAS DECIDED TO REPORT THIS ISSUE BASED ON THE POTENTIAL, AS ANY UNEXPECTED STEAM LEAK FROM PARTS AVAILABLE FOR THE CUSTOMER MIGHT LED TO AN ADVERSE EVENT.
MANUFACTURER'S REFERENCE NUMBER 226991.
MANUFACTURER'S REFERENCE NUMBER: (B)(4).
WE ARE AWARE THAT THIS IS PAST THE 30 DAY DEADLINE FOR REPORTING. WE HAVE REMINDED INVOLVED PERSONS TO REVIEW FDA REPORTING GUIDELINES IN ORDER TO PREVENT THIS FROM HAPPENING AGAIN. THE ISSUE IS BEING INVESTIGATED BY MANUFACTURING SITE.
ON 9TH JULY, 2019 GETINGE BECAME AWARE ABOUT AN ISSUE WITH ONE OF THE STEAM STERILIZER- 833 HC-E. AS IT WAS STATED, LARGE AMOUNT OF STEAM LEAKED FROM THE TOP OF THE DEVICE DOOR. THERE WAS NO INJURY REPORTED, HOWEVER IT WAS DECIDED TO REPORT THIS ISSUE BASED ON THE POTENTIAL, AS ANY UNEXPECTED STEAM LEAK FROM PARTS AVAILABLE FOR THE CUSTOMER MIGHT LED TO AN ADVERSE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 712048 | 800-SERIES | STERILIZER, STEAM | FLE | GETINGE IC PRODUCTION POLAND SP. Z O.O. | 833HC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |