LOADING CART FOR 8668 WASHER DISINFECTOR
Report
- Report Number
- 9616031-2019-00017
- Event Type
- Malfunction
- Date Received
- June 25, 2019
- Report Date
- March 26, 2020
- Manufacturer
- GETINGE DISINFECTION AB
- Product Code
- MEC
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
THE ISSUE IN BEING INVESTIGATED BY A MANUFACTURER SIDE.
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 BEING INVESTIGATED BY MANUFACTURING SITE. H3 OTHER TEXT : DEVICE NOT RETURNED TO THE MNAUFACTURER.
THE ISSUE IS STILL BEING INVESTIGATED BY MANUFACTURING SITE.
WHEN REVIEWING REPORTABLE EVENTS FOR THIS TYPE OF ISSUES WE WERE ABLE TO ESTABLISH THAT THE RECEIVED INCIDENT IS ONE OF SEVERAL REGISTERED FOR ISSUE WITH SHARP EDGES ON THE LOADING TROLLEYS, BUT THE FIRST REGISTERED FOR THIS PARTICULAR SUPPLIER. WHEN THE INCIDENT OCCURRED, THE DEVICE WAS DIRECTLY INVOLVED. THE DEVICE DID NOT MEET ITS SPECIFICATION. UPON THE EVENT OCCURRENCE THE DEVICE WAS NOT BEING USED FOR PATIENT TREATMENT OR DIAGNOSIS. THE DEVICE AFFECTED IS THE LOADING TROLLEY NUMBER 6020720171 USED AS AN ACCESSORY WITH THE 8666 WASHER DISINFECTOR. THE WASHER WAS INSTALLED ON 19TH JULY, 2017. DURING THE INVESTIGATION COURSE, WE WERE ABLE TO ESTABLISH THAT THE OPERATOR NOTICED THE SHARP EDGES ON THE TROLLEY. THERE WAS NO INJURY REPORTED, HOWEVER THE CUSTOMER WAS CONCERNED THAT THE SHARP EDGES ON THE TROLLEY COULD BE A REASON OF THE HAND CUT. THE REASON OF THE MALFUNCTION WAS RELATED TO THE EXTERNAL SUPPLIER, WHO DELIVERS THE TROLLEYS AS A FINISHED PRODUCT. WITH ALL OF THE TROLLEYS, THERE IS THE CONTROL DOCUMENT DELIVERED, WHICH ENSURES, THAT ALL THE TROLLEYS ARE TESTED AND CONTROLLED AFTER THE PRODUCTION AND NO SHARP EDGES WAS DETECTED. THE SUPPLIER WAS INFORMED ABOUT THE EVENT TO DRAW HIS ATTENTION TO THE NEED FOR CAREFUL PRODUCT CONTROL. 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.
THE ISSUE IN BEING INVESTIGATED BY A MANUFACTURER SIDE.
THE ISSUE IN BEING INVESTIGATED BY A MANUFACTURER SIDE.
THE ISSUE IS STILL BEING INVESTIGATED BY MANUFACTURING SITE.
THE ISSUE IS STILL BEING INVESTIGATED BY MANUFACTURING SITE.
MANUFACTURER REFERENCE NUMBER: (B)(4).
ON (B)(6) 2019 GETINGE BECAME AWARE ABOUT AN ISSUE WITH ONE OF THE ACCESSORY- LOADING CART USED WITH 8668 WASHER DISINFECTOR. AS IT WAS STATED, THE PERSON SUSTAINED AN INJURY WHILE OPERATING THE LOADING CART DUE TO SHARP EDGE. THE CIRCUMSTANCES OF THE ISSUE ARE UNKNOWN. THE LOADING CART IS NOT REGISTERED AS A MEDICAL DEVICE ITSELF, HOWEVER THE INJURY SUSTAINED WHILE OPERATING AN ACCESSORY AS A SYSTEM WITH WASHER DISINFECTOR 8668 AND THE ISSUE WILL BE REPORTED SUCH AS.
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).
MANUFACTURER REFERENCE NUMBER: (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 523865 | LOADING CART FOR 8668 WASHER DISINFECTOR | DISINFECTOR, MEDICAL DEVICES | MEC | GETINGE DISINFECTION AB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |