733HC
Report
- Report Number
- 3012068831-2019-00002
- Event Type
- Malfunction
- Date Received
- May 13, 2019
- Report Date
- September 19, 2019
- 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 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.
THE FIELDS B5 (EVENT) AND G4 (DATE REC¿D BY MFR) WERE CORRECTED ACCORDING TO THE INFORMATION RECEIVED FROM COMPANY'S REPRESENTATIVE.
THE ISSUE IS ST8ILL 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. (B)(4).
ON (B)(6), 2019 GETINGE BECAME AWARE ABOUT AN ISSUE WITH ONE OF OUR DEVICES- 733HC STEAM STERILIZER. IT WAS STATED THAT THE CARRIAGE HAS NOT LATCHED TO THE DEVICE PROPERLY AND CART FELL INTO THE FLOOR. THERE WAS NO INJURY REPORTED. WHEN REVIEWING REPORTABLE EVENTS, WE WERE ABLE TO ESTABLISH THAT THIS IS A SECOND COMPLAINT REPORTED TO GETINGE REGARDING THIS FAILURE MODE. NO APPARENT TREND WAS NOTICED. THE PRODUCT INVOLVED IN THE INCIDENT IS THE 733HC STEAM STERILIZER WITH THE SERIAL NUMBER (B)(6). THE UNIT WAS MANUFACTURED ON 6TH DECEMBER, 2018. AFTER THE ISSUE OCCURRENCE, THE DEVICE WAS INSPECTED BY GETINGE TECHNICIAN WHO CONFIRMED THE ALLEGED SITUATION AND NOTICED BENT LATCHING BRACKET, WHICH WAS ADJUSTED AND THEN THE CARRIAGE WAS RETURNED FOR CUSTOMER USAGE. THE MANUFACTURER REPRESENTATIVE, SUPPORTED BY INPUT FROM TECHNICIAN WHO VISITED THE CUSTOMER, HAS INVESTIGATED THE COMPLAINT AT HAND. IT WAS CONFIRMED THAT WHEN THE CUSTOMER PULLED OUT THE CART, THE CARRIAGE WAS NOT LOCK PROPERLY AND CART FELL INTO THE FLOOR. THE SITUATION TOOK PLACE, MOST LIKELY, DUE TO CUSTOMER NOT FOLLOWING THE INSTRUCTION PROVIDED IN USER MANUAL. ADDITIONALLY, IT WAS NOTICED BY THE TECHNICIAN THAT THE FLOOR IN THE FRONT OF THE STERILIZER IN NOT LEVEL, WHICH COULD RESULT IN THE DIFFICULTIES IN LOCKING THE CARRIAGE. GETINGE TECHNICIAN RETRAINED THE CUSTOMER ON HOW TO PROPERLY LOCK CARRIAGE TO STERILIZER. IT WAS NOTICED TO THE USER THAT, ACCORDING TO USER MANUAL, A SLIGHT PULL IS REQUIRED TO VERIFY IF THE CARRIAGE IS LOCKED TO THE UNIT. IN SUMMARY, WHEN THE EVENT OCCURRED, THE DEVICE DID NOT MEET ITS SPECIFICATION AND IT CONTRIBUTED TO THE EVENT. IN THE TIME WHEN THE EVENT OCCURRED, THE DEVICE WAS NOT BEING USED FOR PATIENT TREATMENT. GIVEN THE FINDINGS OF THIS INVESTIGATION GETINGE SHALL CONTINUE TO MONITOR FOR ANY FURTHER EVENTS OF THIS NATURE AND DOES NOT PROPOSE ANY OTHER ACTION AT THIS TIME.
THE ISSUE IS STILL BEING INVESTIGATING BY MANUFACTURING SITE.
ON (B)(6) 2019 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF THE STERILIZERS- 733HC. IT WAS STATED THAT THE CARRIAGE HAS NOT LATCH TO THE DEVICE PROPERLY AND CART FELL INTO THE FLOOR. THERE WAS NO INJURY REPORTED HOWEVER IT WAS DECIDED TO REPORT THIS ISSUE BASED ON THE POTENTIAL AS ANY CARTS FALLING OFF FROM THE DEVICE MIGHT LEAD TO AN ADVERSE EVENT. (B)(4).
ON 6TH MAY, 2019 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF THE STERILIZERS- 733HC. IT WAS STATED THAT THE CARRIAGE HAS NOT LATCH TO THE DEVICE PROPERLY AND CART FELL INTO THE FLOOR. THERE WAS NO INJURY REPORTED HOWEVER IT WAS DECIDED TO REPORT THIS ISSUE BASED ON THE POTENTIAL AS ANY CARTS FALLING OFF FROM THE DEVICE 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).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 396569 | 733HC | STERILIZER, STEAM | FLE | GETINGE IC PRODUCTION POLAND SP. Z O.O. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |