inforMED
MalfunctionLHC

WARMING CABINETS

Received Feb 28, 2020 · Event occurred Feb 25, 2020

Report 3012068831-2020-00002 · MDR key 9769494

Device

Generic name

Warmer, Irrigation Solution

Model number

5624

Catalog number

SZ5624XBR

Product problems

  • Sharp Edges
  • Sharp Edges

Patient

Not reported

  • No Known Impact Or Consequence To Patient
  • No Known Impact Or Consequence To Patient

Narrative

Additional Manufacturer Narrative

THE ISSUE IS BEING INVESTIGATED BY THE MANUFACTURING SITE. DEVICE NOT RETURNED TO MANUFACTURER.

Description of Event or Problem

ON 25TH FEBRUARY, 2020 GETINGE BECAME AWARE OF AN ISSUE WITH WARMING CABINETS 5624. AS IT WAS STATED, THE SHARP EDGES OF SHELVES CONTRIBUTED TO STAFF BODY CUTS DURING LOADING / UNLOADING CABINETS. THERE WAS NO INFORMATION PROVIDED IF EMPLOYEES NEEDED MEDICAL INTERVENTION HOWEVER, WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL AS SUCH SITUATION MAY LEAD TO SERIOUS INJURY OR WORSE.

Description of Event or Problem

MANUFACTURER REFERENCE NUMBER (B)(4).

Additional Manufacturer Narrative

GETINGE BECAME AWARE OF AN ISSUE WITH WARMING CABINETS 5624. AS IT WAS STATED, THE SHARP EDGES OF SHELVES CONTRIBUTED TO CUSTOMER STAFF BODY CUTS DURING LOADING / UNLOADING CABINETS. THERE WAS NO INFORMATION PROVIDED IF EMPLOYEES NEEDED MEDICAL INTERVENTION HOWEVER, WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL AS SUCH SITUATION MAY LEAD TO SERIOUS INJURY OR WORSE. WHEN REVIEWING REPORTABLE EVENTS FOR THIS TYPE OF ISSUES WE WERE NOT ABLE TO FIND ANY SIMILAR REPORTABLE COMPLAINTS WHERE THE SHARP EDGES OF SHELVES LED TO CUSTOMER PERSONNEL RECEIVING SKIN CUTS. WHEN THE EVENT OCCURRED, THE DEVICE ACCORDING TO SUBJECT MATTER EXPERT INFORMATION DID MEET ITS SPECIFICATION. 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 PERSONNEL GOT CUT DURING USING THE WARMING CABINETS DUE TO IMPROPER USAGE OF WARMING CABINETS, NAMELY LACK OF PROTECTIVE CLOTHING AND OVERLOADING THE WARMING CABINETS. WE CURRENTLY DO NOT HAVE ANY INFORMATION THAT WOULD WARRANT FURTHER ACTION TOWARDS THE 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. AS DEVICE IS NO LONGER MANUFACTURED, NO FURTHER ACTIONS TOWARDS DEVICE MANUFACTURING WILL BE PROVIDED.