WARMING CABINETS
Received Jul 17, 2024 · Event occurred Jul 5, 2024
Report 3012068831-2024-00001 · MDR key 19759959
Device
Generic name
Warmer, Irrigation Solution
Manufacturer
Getinge Ic Production Poland Sp. Z O.o.Model number
5624Catalog number
SZ5624XBR
Lot number
N/A
Product problems
- Sharp Edges
- Sharp Edges
Patient
NA · Unknown
- Abrasion
- Abrasion
Narrative
Additional Manufacturer Narrative
GETINGE BECAME AWARE OF INCIDENT WITH THE WARMING CABINET, MODEL 5624. AS IT WAS STATED BY THE GETINGE TECHNICIAN, WHILE LOADING THE UNIT, CUSTOMER CUT THUMB ON SHARP EDGES OF SHELVE. CUSTOMER PROVIDED INFORMATION THAT STERI-STRIPS WERE APPLIED ON THUMB. WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL AS THE DESCRIBED EVENT COULD LEAD TO SERIOUS INJURY. WHEN REVIEWING REPORTABLE EVENTS FOR THIS TYPE OF ISSUE FOR 5624 WARMING CABINET WE WERE ABLE TO ESTABLISH THAT THE RECEIVED INCIDENT IS THE SECOND ONE REGISTERED IN GETINGE COMPLAINT HANDLING SYSTEMS OF ITS KIND. FORTUNATELY, THE EVENTS HAVE NOT LED TO SERIOUS INJURY OR WORSE. WHEN THE EVENT OCCURRED, THE DEVICE DID MEET ITS SPECIFICATIONS AND CONTRIBUTED TO THE EVENT. THE DEVICE WAS NOT BEING USED FOR PATIENT TREATMENT WHEN THE EVENT TOOK PLACE. BASED ON THE PERFORMED ROOT CAUSE ANALYSIS AND INPUT FROM THE SUBJECT MATTER EXPERT AND THE GETINGE TECHNICIAN WHO VISITED THE CUSTOMER WE CONCLUDE THAT THE MOST PROBABLE ROOT CAUSE IS RELATED TO USER. THE INJURY SUSTAINED COULD HAVE BEEN PREVENTED IF THE USER WORN THE APPROPRIATE GLOVES REQUIRED FOR HANDLING HOT LOADS DURING LOADING/UNLOADING THE WARMING CABINET AS MENTIONED IN USER MANUAL. WE CURRENTLY DO NOT HAVE ANY INFORMATION THAT WOULD WARRANT FURTHER ACTION TOWARDS THE DEVICES, HOWEVER AS PER OUR COMPLAINT HANDLING PROCESSES, WE WILL CONTINUE TO MONITOR THE CUSTOMER EXPERIENCES WITH THE DEVICE FOR ANY FUTURE INFORMATION.
Description of Event or Problem
MANUFACTURER'S REFERENCE NUMBER: (B)(4).
Additional Manufacturer Narrative
RELATED REPORT NUMBER - 0504540000-2024-8012. ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION.
Description of Event or Problem
ON 9TH JULY 2024, GETINGE BECAME AWARE OF INCIDENT WITH THE WARMING CABINET, MODEL 5624. AS IT WAS STATED BY THE GETINGE TECHNICIAN, WHILE LOADING THE UNIT, CUSTOMER CUT THUMB ON SHARP EDGES OF SHELVE. CUSTOMER PROVIDED INFORMATION THAT STERI-STRIPS WERE APPLIED ON THUMB. WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL AS THE DESCRIBED EVENT COULD LEAD TO SERIOUS INJURY.