833HC-E
Report
- Report Number
- 3012068831-2019-00004
- Event Type
- Malfunction
- Date Received
- June 24, 2019
- Report Date
- February 19, 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 BEING INVESTIGATED BY MANUFACTURING SITE. THIS REPORT IS BEING FILED UNDER EXEMPTION E2017051 BY THE MANUFACTURER GETINGE IC PRODUCTION POLAND SP. Z.O.O, (REGISTRATION NO. 3012068831) ON BEHALF OF THE IMPORTER GETINGE GROUP LOGISTICS AMERICA, LLC, (REGISTRATION NO. 3012092534) H3 OTHER TEXT : DEVICE NOT RETURNED TO THE MANUFACTURER.
GETINGE BECAME INFORMED OF AN ISSUE WITH A STEAM STERILIZER 833HC-E DEVICE WITH SERIAL NUMBER (B)(6) THAT WAS DESCRIBED BY CUSTOMER AS LARGE AMOUNT OF STEAM LEAKED IN THE FRONT OF THE DEVICE INTO THE ROOM. 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 DOOR AREA AT THE VARIOUS REASONS. FORTUNATELY THE EVENT HAS NOT LED TO SERIOUS INJURY OR WORSE. THE DEVICE WAS MANUFACTURED ON 22TH SEPTEMBER 2014. THE DHR FOR THE DEVICE WAS REVIEWED AND NO RELATED ANOMALIES WERE FOUND. THE DEVICE WAS RELEASED TO THE CUSTOMER IN A FULLY WORKING CONDITION. PREVENTIVE MAINTENANCE (PM) IS BEING PERFORMED UNDER GETINGE AGREEMENT. LAST PM BEFORE THE EVENT WAS PERFORMED ON 29TH 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 STERILIZER WAS CAUSED BY BAD ALIGNMENT OF THE DOOR. AS FOR WHAT CAUSED THE INCORRECT DOOR POSITION, IT APPEARS THE MOST LIKELY CAUSE RELATES TO PREVENTIVE MAINTENANCE INSTRUCTION NOT BEING FOLLOWED. 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 BRAND NAME # SECTIONS AND SERIAL NUMBER INCLUDED IN SERIAL # SECTION. THIS IS BASED ON THE RESULT OF AN INTERNAL REVIEW NOTING THE REPORT WAS INCORRECTLY SUBMITTED STATING ANOTHER MODEL NAME. SERIAL NUMBER WAS CLARIFIED BY COMMUNICATION WITH GETINGE TECHNICIAN. #B5: PREVIOUS DESCRIBE EVENT OR PROBLEM: ON 17TH JUNE, 2019 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF THE STEAM STERILIZER- 833HC MODEL NUMBER. AS IT WAS STATED BY THE CUSTOMER, LARGE AMOUNT OF STEAM LEAKED IN THE FRONT OF THE DEVICE INTO THE ROOM. THERE WAS NO INJURY REPORTED, HOWEVER IT WAS DECIDED TO REPORT THIS ISSUE BASED ON THE POTENTIAL, AS ANY STEAM LEAK FROM PARTS AVAILABLE FOR CUSTOMER MIGHT LEAD TO AN ADVERSE EVENT. CORRECTED DESCRIBE EVENT OR PROBLEM: ON 17TH JUNE, 2019 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF THE STEAM STERILIZER- 833HC-E MODEL NUMBER. AS IT WAS STATED BY THE CUSTOMER, LARGE AMOUNT OF STEAM LEAKED IN THE FRONT OF THE DEVICE INTO THE ROOM. THERE WAS NO INJURY REPORTED, HOWEVER IT WAS DECIDED TO REPORT THIS ISSUE BASED ON THE POTENTIAL, AS ANY STEAM LEAK FROM PARTS AVAILABLE FOR CUSTOMER MIGHT LEAD TO AN ADVERSE EVENT. #D4: PREVIOUS BRAND NAME #: 833HC. PREVIOUS SERIAL #: (B)(6). CORRECTED BRAND NAME #: 833HC-E. CORRECTED SERIAL #: (B)(6).
THE ISSUE IS STILL BEING INVESTIGATED BY MANUFACTURING SITE.
THE ISSUE IS STILL BEING INVESTIGATED BY MANUFACTURING SITE.
THE ISSUE IS STILL INVESTIGATED BY THE MANUFACTURING SITE.
THE ISSUE IS STILL BEING INVESTIGATED BY THE MANUFACTURING SITE.
THE ISSUE IS STILL BEING INVESTIGATED BY MANUFACTURING SITE.
MANUFACTURER REFERENCE NUMBER: (B)(4).
ON 17TH JUNE, 2019 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF THE STEAM STERILIZER- 833HC MODEL NUMBER. AS IT WAS STATED BY THE CUSTOMER, LARGE AMOUNT OF STEAM LEAKED IN THE FRONT OF THE DEVICE INTO THE ROOM. THERE WAS NO INJURY REPORTED, HOWEVER IT WAS DECIDED TO REPORT THIS ISSUE BASED ON THE POTENTIAL, AS ANY STEAM LEAK FROM PARTS AVAILABLE FOR CUSTOMER MIGHT LEAD TO AN ADVERSE EVENT.
ON 17TH JUNE, 2019 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF THE STEAM STERILIZER- 833HC-E MODEL NUMBER. AS IT WAS STATED BY THE CUSTOMER, LARGE AMOUNT OF STEAM LEAKED IN THE FRONT OF THE DEVICE INTO THE ROOM. THERE WAS NO INJURY REPORTED, HOWEVER IT WAS DECIDED TO REPORT THIS ISSUE BASED ON THE POTENTIAL, AS ANY STEAM LEAK FROM PARTS AVAILABLE FOR CUSTOMER MIGHT LEAD TO AN ADVERSE EVENT.
MANUFACTURER REFERENCE NUMBER: (B)(4).
MANUFACTURER REFERENCE NUMBER: (B)(4).
MANUFACTURER REFERENCE NUMBER: (B)(4).
MANUFACTURER REFERENCE NUMBER: (B)(4).
MANUFACTURER REFERENCE NUMBER: (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 520893 | 833HC-E | STERILIZER, STEAM | FLE | GETINGE IC PRODUCTION POLAND SP. Z O.O. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |