9100-SERIES
Report
- Report Number
- 9616031-2017-00004
- Event Type
- Injury
- Date Received
- March 10, 2017
- Date of Event
- February 8, 2017
- Report Date
- December 11, 2017
- Manufacturer
- GETINGE DISINFECTION AB
- Product Code
- MEC
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
THIS REPORT IS BEING FILED UNDER EXEMPTION E2016015 BY THE MANUFACTURER GETINGE DISINFECTION AB, (REGISTRATION NO. 9616031) ON BEHALF OF THE IMPORTER GETINGE USA, INC., (REGISTRATION NO. 3004147784). ADDITIONAL INFORMATION WILL BE PROVIDED UPON RESULTS OF THE INVESTIGATION.
THIS REPORT IS BEING FILED UNDER EXEMPTION E2016015 BY THE MANUFACTURER GETINGE DISINFECTION AB, (REGISTRATION NO. 9616031) ON BEHALF OF THE IMPORTER GETINGE USA, INC., (REGISTRATION NO. 3004147784). THE EVENT IS STILL BEING INVESTIGATED BY THE MANUFACTURING SITE. ADDITIONAL INFORMATION WILL BE PROVIDED UPON RESULTS OF THE INVESTIGATION.
THIS REPORT IS BEING FILED UNDER EXEMPTION E2016015 BY THE MANUFACTURER GETINGE DISINFECTION AB, (REGISTRATION NO. 9616031) ON BEHALF OF THE IMPORTER GETINGE USA, INC., (REGISTRATION NO. 3004147784). THE INVESTIGATION HAS BEEN FINALIZED, HOWEVER THE ROOT CAUSE OF THE ISSUE NEED TO BE CONFIRMED. ADDITIONAL INFORMATION WILL BE PROVIDED UPON RESULTS OF THE INVESTIGATION.
THIS REPORT IS BEING FILED UNDER EXEMPTION E2016015 BY THE MANUFACTURER GETINGE DISINFECTION AB, (REGISTRATION NO. 9616031) ON BEHALF OF THE IMPORTER GETINGE USA, INC., (REGISTRATION NO. 3004147784). THE EVENT IS BEING INVESTIGATED BY THE MANUFACTURING SITE. ROOT CAUSE OF THE FAILURE IS BEING ESTABLISHED. ADDITIONAL INFORMATION WILL BE PROVIDED UPON RESULTS OF THE INVESTIGATION.
THIS REPORT IS BEING FILED UNDER EXEMPTION E2016015 BY THE MANUFACTURER GETINGE DISINFECTION AB, (REGISTRATION NO. 9616031) ON BEHALF OF THE IMPORTER GETINGE USA, INC., (REGISTRATION NO. 3004147784). THE EVENT IS BEING INVESTIGATED BY THE MANUFACTURING SITE. ADDITIONAL INFORMATION WILL BE PROVIDED UPON RESULTS OF THE INVESTIGATION.
THIS REPORT IS BEING FILED UNDER EXEMPTION E2016015 BY THE MANUFACTURER GETINGE DISINFECTION AB, (REGISTRATION NO. 9616031) ON BEHALF OF THE IMPORTER GETINGE USA, INC., (REGISTRATION NO. 3004147784). GETINGE RECEIVED A COMPLAINT WHERE ONE OF THE STAFF MEMBERS AT THE CUSTOMER SITE HURT THEIR BACK WHILE REMOVING A WASH CART (WHICH IS NOT CONSIDERED TO BE A MEDICAL DEVICE ITSELF) FROM THE 9100-SERIES WASHER DISINFECTOR, WHICH IS A MEDICAL DEVICE. INVESTIGATION ON THIS ISSUE WAS PERFORMED. IT WAS FOUND THAT THE WASH CART WAS DAMAGED IN A WAY THAT WOULD HAVE MADE REMOVING A DIFFICULT AND STRENUOUS TASK. IT WAS NOT POSSIBLE TO COLLECT MORE DETAILS RELATED TO THE ALLEGED INJURIES OF THE INVOLVED PERSON SINCE THE CUSTOMER DECIDED NOT TO PROVIDE WITH FURTHER INFORMATION, CITING HEALTHCARE PRIVACY LAWS. WHEN THE EVENT OCCURRED THE DEVICE WAS NOT USED FOR TREATMENT OR DIAGNOSIS. THE WASHER DISINFECTOR WAS UP TO SPECIFICATION WHEN THE EVENT TOOK PLACE. THE WASH CART (AN ACCESSORY TO THE MEDICAL DEVICE) WAS NOT. ACCORDING TO USER MANUAL FOR 9100-SERIES (6001341202, REV. D) WASHER DISINFECTOR; THE CUSTOMER IS RESPONSIBLE TO CHECK THE DEVICE IS UP TO SPECIFICATION BEFORE USE. AS STATED IN THE MENTIONED MANUAL ON PAGE 34 IT IS DESCRIBED THAT DAILY CHECK OF THE DEVICE SHOULD INCLUDE CHECKING OF THE ACCESSORIES ON THE MACHINE: "CHECK THE ACCESSORIES OF THE MACHINE VISUALLY WITH REGARD TO THEIR INTENDED USE AND FUNCTION, E.G., BLOCKED DUCTS, WORN AND MISSING PARTS THAT MIGHT AFFECT THE PERFORMANCE OF THE MACHINE. THE WATER MUST BE ABLE TO FLOW FREELY THROUGH THE DUCTS OF TUBULAR INSTRUMENTS.". MOREOVER THE SAME USER MANUAL INCLUDES ALSO INFORMATION ABOUT CHECKING PROPER DOCKING OF THE WASH CART IN THE CASE WHEN THE WASHER-DISINFECTOR IS EQUIPPED WITH OPTIONAL DOCKING FOR WASH CART: "CHECK THAT THE WASH CART DOCKS CORRECTLY TO THE DOCKING UNIT IN THE FLOOR." IT WAS ESTABLISHED THAT THE ROOT CAUSE OF THE FAILURE WAS THE TEAR AND WEAR OF THE WHEELS OF THE WASH CART USED WITH THE 9100-SERIES WASHER DISINFECTOR. DAMAGED PARTS HAVE BEEN REPLACED AFTER THE EVENT, THE WASH CART WAS PUT BACK IN USE. WE BELIEVE THAT IF THE CUSTOMER WOULD FOLLOW DAILY ROUTINE DESCRIBED IN THE USER MANUAL OF CHECKING THE EQUIPMENT THE INCIDENT WOULD HAVE BEEN AVOIDED. ACCORDING TO OUR KNOWLEDGE IT IS NOT LIKELY THAT THE PERSON WOULD RECEIVE A SERIOUS INJURY FROM USE OF THE WASH CART WITH TEARED WHEELS, HOWEVER WE REPORT THIS CASE IN ABUNDANCE OF CAUTION AS WE WERE INFORMED ABOUT AN ALLEGATION OF THE INJURY.
THIS REPORT IS BEING FILED UNDER EXEMPTION E2016015 BY THE MANUFACTURER GETINGE DISINFECTION AB, (REGISTRATION NO. 9616031) ON BEHALF OF THE IMPORTER GETINGE USA, INC., (REGISTRATION NO. 3004147784). THE EVENT IS BEING INVESTIGATED. ADDITIONAL INFORMATION WILL BE PROVIDED UPON RESULTS OF THE INVESTIGATION.
ON 9TH FEBRUARY 2017 WE BECAME AWARE OF AN INCIDENT OCCURRED WITH ONE OF GETINGE 9100-SERIES WASHER DISINFECTOR. AS IT WAS STATED BY THE CUSTOMER ONE OF THE STAFF MEMBER HURT THEIR BACK WHILE HE WAS REMOVING A CART FROM THE WASHER. GETINGE REPRESENTATIVE WHO ARRIVED ON SITE CONCLUDED THAT THE WHEELS FOR INSTRUMENT AND CONTAINER RACK NEED TO BE REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 177286 | 9100-SERIES | MEC | MEC | GETINGE DISINFECTION AB | 9125 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |