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GETINGE 86-SERIES S-8668 (REF S-86682003)Recalls & reported problems

Getinge Disinfection AB · WASHER DISINFECTOR Cat. No. updated from S-86681003 to S-86682003 · Class 2

All models of GETINGE 86-SERIES (5)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Quick summary

This Getinge 86-series S-8668 washer disinfector is a machine that washes and disinfects medical instruments and carts. Most of the 37 reports describe loading carts or racks falling over or detaching, sometimes dropping disinfected goods to the floor, plus installation-related problems. Two injuries are reported, including a staff member who allegedly lost consciousness after an electric shock while changing soap. There are no deaths. One recall, started in March 2018 and closed, involved software that could let a cart unload without being docked.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports
37
Deaths reported
0
Injuries reported
2
Recalls naming it
1

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 07340153700277), received between Jun 14, 2017 and Apr 13, 2026 — classified as 2 injuries, 35 malfunctions.

The most frequently reported specific device problem is “Device Fell” (12 reports).

1 FDA recall record name this device's identifier.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 3 reportsMar 2024: 5 reportsApr 2024: 1 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 1 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520265
Last 36 months. The most recent month may be incomplete.

Recalls naming this device

  1. Mar 2, 2018Terminated

    There is potential for a cart with disinfected goods to unload without the trolley being docked. Disinfected goods could end up falling to the floor causing risk to nearby users and damage to goods and equipment.

    Z-1379-2018 · Root cause: Software design · Recall details · FDA record ↗

Most reported problems

Device problems

  • Device Fell12
  • Detachment of Device or Device Component11
  • Device Dislodged or Dislocated5
  • Installation-Related Problem4
  • Break2
  • Component Falling2
  • Device Handling Problem2
  • Corroded1

Patient problems

  • No Clinical Signs, Symptoms or Conditions27
  • Electric Shock1
  • Injury1
  • Insufficient Information1
  • Laceration(s)1
  • Limb Pain1
  • No Known Impact Or Consequence To Patient1
  • No Patient Involvement1

Recent adverse event reports

The 25 most recent of 37 reports, in the reporter's own words as published by the FDA.

  • InjuryApr 13, 2026Electrical /Electronic Property Problem

    A CUSTOMER REPORTED AN INCIDENT IN WHICH A STAFF MEMBER ALLEGEDLY EXPERIENCED AN ELECTRIC SHOCK WHILE ATTEMPTING TO REPLACE SOAP IN THE UNIT. ACCORDING TO THE ALLEGATION, THE INDIVIDUAL LOST CONSCIOUSNESS AND WAS SUBSEQUENTLY TRANSPORTED TO THE EMERGENCY ROOM. ADDITIONAL INFORMATION OBTAINED FROM FOLLOW-UP COMMUNICATION INDICATES THAT THE STAFF MEMBER MAY HAVE BEEN ATTEMPTING TO ADDRESS A DRAIN-RELATED ISSUE AT THE TIME OF THE INCIDENT. THE INDIVIDUAL WAS HOSPITALIZED FOR APPROXIMATELY THREE DAYS AND REMAINED UNDER MEDICAL SUPERVISION, ALTHOUGH SPECIFIC DIAGNOSTIC PROCEDURES AND FINDINGS WERE NOT PROVIDED. NO MEDICAL LEAVE WAS REPORTED FOLLOWING DISCHARGE. A SERVICE TECHNICIAN WAS DISPATCHED TO THE SITE TO INVESTIGATE THE REPORTED EVENT. UPON ARRIVAL, THE TECHNICIAN OBSERVED THAT THE SERVICE PANEL ADJACENT TO THE WASHER HAD BEEN REMOVED. A COMPREHENSIVE INSPECTION OF THE EQUIPMENT WAS CONDUCTED, INCLUDING VERIFICATION OF CIRCUIT BREAKERS (NO TRIPPED BREAKERS FOUND), INSPECTION FOR SIGNS OF OVERHEATING OR ELECTRICAL DAMAGE (NO ABNORMAL ODORS OR BURNED COMPONENTS DETECTED), AND ASSESSMENT OF WIRING AND CONNECTIONS, INCLUDING INCOMING THREE-PHASE POWER AND GROUNDING. ALL CONNECTIONS W

    Patient problems: Electric Shock

    MAUDE report 24857978 ↗
  • MalfunctionApr 17, 2024Use of Device Problem; Device Fell; Use of Device Problem; Device Fell

    MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Patient problems: Limb Pain; Pain

    MAUDE report 19123424 ↗
  • MalfunctionMar 22, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

    ON (B)(6) 2024 GETINGE BECAME AWARE OF AN ISSUE RELATED TO THE 86-SERIES WASHER DISINFECTOR, WITH THE MODEL NAME 8668. IT WAS ALLEGED THAT THERE WERE LOADING ISSUES. THE GETINGE SERVICE TECHNICIAN VISITED THE SITE AND FOUND THAT CART HAD FALLEN OF THE LOADING TROLLEY TO THE GROUND. IT WAS CAUSED BY A MECHANICAL FAILURE ON THE LOADING TROLLEY. THE TROLLEY WAS REPAIRED AND THE UNIT WAS HANDED BACK TO THE CUSTOMER IN A FULLY WORKING CONDITION. THERE WAS NO INJURY OR DAMAGE REPORTED, HOWEVER WE DECIDED TO REPORT THE ISSUE BASED ON A POTENTIAL AS CARTS FALLING OFF THE TROLLEY COULD BRING A HAZARDOUS SITUATION FOR THE OPERATOR AND LEAD TO SERIOUS INJURY IF THE SITUATION WAS TO REOCCUR.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18957584 ↗
  • MalfunctionMar 12, 2024Device Fell; Device Fell

    ON FEBRUARY 29, 2024 GETINGE BECAME AWARE OF AN ISSUE RELATED TO THE AUTOMATION LOADING SYSTEM WITH THE MODEL NAME: AGS 2.0. THE GETINGE AGS 2.0 IS NOT REGISTERED AS A MEDICAL DEVICE, HOWEVER UPON THE SITUATION OCCURRENCE IT WAS USED WITH THE FOUR MEDICAL DEVICES - 86-SERIES WASHER DISINFECTORS WITH THE MODEL NAME: 8668. AS IT WAS STATED, THE RACK ALMOST FELL ON THE FLOOR. GATHERED INFORMATION ALLOWED US TO ESTABLISH THAT DEVICE WAS RESTARTED AND IT WAS RETURNED TO THE SERVICE IN FULL WORKING CONDITION. THERE WAS NO ALLEGATION OF INJURY HOWEVER, WE DECIDED TO REPORT THE ISSUE BASED ON A POTENTIAL AS A RACK FALLING TO THE FLOOR COULD BRING A HAZARDOUS SITUATION FOR THE OPERATOR AND LEAD TO SERIOUS INJURY IF THE SITUATION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18884408 ↗
  • MalfunctionMar 12, 2024Device Fell; Device Fell

    MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18884319 ↗
  • MalfunctionMar 12, 2024Device Fell; Device Fell

    MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18884317 ↗
  • MalfunctionMar 12, 2024Device Fell; Device Fell

    MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18884316 ↗
  • MalfunctionFeb 9, 2024Device Fell; Device Fell

    MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18674401 ↗
  • MalfunctionFeb 8, 2024Device Fell; Device Fell

    ON (B)(6) 2024 GETINGE BECAME AWARE OF AN ISSUE WITH A LOADING TROLLEY WITH A SERIAL NUMBER: (B)(6) , WHICH WAS USED WITH ONE OF THREE 86-SERIES WASHER-DISINFECTORS WITH SERIAL NUMBERS:(B)(6) . A CUSTOMER ALLEGATION WAS THAT THE TROLLEY IS MISSING STOPPER. GETINGE TECHNICIAN VISITED SITE AND WAS INFORMED THAT THE TROLLEY HAD BEEN PUSHED ONTO THE LOADER INCORRECTLY AND HAD FALLEN ON THE FLOOR SNAPPING OF ONE OF THE ARMS ON THE CARRIER. SO FAR, WE HAVE NOT BEEN INFORMED ABOUT ANY ADVERSE CONSEQUENCES OF REPORTED ISSUE, HOWEVER WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL AS THE TROLLEY FALLING TO THE GROUND MAY RESULT IN A SERIOUS INJURY IF THE SITUATION WAS TO REOCCUR.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18668301 ↗
  • MalfunctionFeb 8, 2024Device Fell; Device Fell

    ON JANUARY 16, 2024 GETINGE BECAME AWARE OF AN ISSUE WITH A LOADING TROLLEY WITH A SERIAL NUMBER: (B)(6), WHICH WAS USED WITH ONE OF THREE 86-SERIES WASHER-DISINFECTORS WITH SERIAL NUMBERS: (B)(6). A CUSTOMER ALLEGATION WAS THAT THE TROLLEY IS MISSING STOPPER. GETINGE TECHNICIAN VISITED SITE AND WAS INFORMED THAT THE TROLLEY HAD BEEN PUSHED ONTO THE LOADER INCORRECTLY AND HAD FALLEN ON THE FLOOR SNAPPING OF ONE OF THE ARMS ON THE CARRIER. SO FAR, WE HAVE NOT BEEN INFORMED ABOUT ANY ADVERSE CONSEQUENCES OF REPORTED ISSUE, HOWEVER WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL AS THE TROLLEY FALLING TO THE GROUND MAY RESULT IN A SERIOUS INJURY IF THE SITUATION WAS TO REOCCUR.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18666310 ↗
  • MalfunctionOct 27, 2023Corroded; Device Fell; Corroded; Device Fell

    MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18020028 ↗
  • MalfunctionSep 15, 2023Device Fell; Device Fell

    ON SEPTEMBER 13, 2023 GETINGE BECAME AWARE OF AN ISSUE RELATED TO THE 86-SERIES WASHER DISINFECTOR, WITH THE MODEL NAME 8668. AS IT WAS STATED, THE CART FELL TO THE GROUND. THERE WAS NO ALLEGATION OF INJURY HOWEVER, WE DECIDED TO REPORT THE ISSUE BASED ON A POTENTIAL AS A CART FALLING TO THE FLOOR COULD BRING A HAZARDOUS SITUATION FOR THE OPERATOR AND LEAD TO SERIOUS INJURY IF THE SITUATION REOCCURS.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17753907 ↗
  • MalfunctionJul 21, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

    ON 7TH JULY, 2023 GETINGE BECAME AWARE OF AN ISSUE RELATED TO THE 86-SERIES WASHER DISINFECTOR, WITH THE MODEL NAME 8668. AS IT WAS STATED, CARTS FELL OFF THE TROLLEY. THERE WAS NO INJURY OR DAMAGE REPORTED, HOWEVER WE DECIDED TO REPORT THE ISSUE BASED ON A POTENTIAL AS CARTS FALLING OFF THE TROLLEY COULD BRING A HAZARDOUS SITUATION FOR THE OPERATOR AND LEAD TO SERIOUS INJURY IF THE SITUATION WAS TO REOCCUR.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17369417 ↗
  • MalfunctionMar 1, 2023Installation-Related Problem; Installation-Related Problem

    ON 17TH FEBRUARY, 2023 GETINGE BECAME AWARE OF AN ISSUE RELATED TO THE WASHER DISINFECTOR WITH THE MODEL NAME 8668. AS IT WAS STATED, THE INCORRECT DETERGENT DOSING AND FINAL RINSE WERE SET ON THE DEVICE FOR ONE OF THE PROGRAMS. THE WASHER DISINFECTOR WAS USED IN THIS STATE WITHOUT ANY CORRECTION OF THE PROGRAM SETTINGS FOR ABOUT 1 YEAR. WE HAVE NO INFORMATION ABOUT ANY ADVERSE OUTCOME DUE TO THE ISSUE, HOWEVER WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION, THAT ANY IMPROPERLY CLEANED LOADS USED FOR PATIENTS¿ TREATMENT COULD BE THE SOURCE OF INFECTION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16458679 ↗
  • MalfunctionMar 1, 2023Installation-Related Problem; Installation-Related Problem

    ON 17TH FEBRUARY, 2023 GETINGE BECAME AWARE OF AN ISSUE RELATED TO THE WASHER DISINFECTOR WITH THE MODEL NAME 8668. AS IT WAS STATED, THE INCORRECT DETERGENT DOSING AND FINAL RINSE WERE SET ON THE DEVICE FOR ONE OF THE PROGRAMS. THE WASHER DISINFECTOR WAS USED IN THIS STATE WITHOUT ANY CORRECTION OF THE PROGRAM SETTINGS FOR ABOUT 1 YEAR. WE HAVE NO INFORMATION ABOUT ANY ADVERSE OUTCOME DUE TO THE ISSUE, HOWEVER WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION, THAT ANY IMPROPERLY CLEANED LOADS USED FOR PATIENTS¿ TREATMENT COULD BE THE SOURCE OF INFECTION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16458678 ↗
  • MalfunctionMar 1, 2023Installation-Related Problem; Installation-Related Problem

    ON 17TH FEBRUARY, 2023 GETINGE BECAME AWARE OF AN ISSUE RELATED TO THE WASHER DISINFECTOR WITH THE MODEL NAME 8668. AS IT WAS STATED, THE INCORRECT DETERGENT DOSING AND FINAL RINSE WERE SET ON THE DEVICE FOR ONE OF THE PROGRAMS. THE WASHER DISINFECTOR WAS USED IN THIS STATE WITHOUT ANY CORRECTION OF THE PROGRAM SETTINGS FOR ABOUT 1 YEAR. WE HAVE NO INFORMATION ABOUT ANY ADVERSE OUTCOME DUE TO THE ISSUE, HOWEVER WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION, THAT ANY IMPROPERLY CLEANED LOADS USED FOR PATIENTS¿ TREATMENT COULD BE THE SOURCE OF INFECTION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16458676 ↗
  • MalfunctionMar 1, 2023Installation-Related Problem; Installation-Related Problem

    ON 17TH FEBRUARY, 2023 GETINGE BECAME AWARE OF AN ISSUE RELATED TO THE WASHER DISINFECTOR WITH THE MODEL NAME 8668. AS IT WAS STATED, THE INCORRECT DETERGENT DOSING AND FINAL RINSE WERE SET ON THE DEVICE FOR ONE OF THE PROGRAMS. THE WASHER DISINFECTOR WAS USED IN THIS STATE WITHOUT ANY CORRECTION OF THE PROGRAM SETTINGS FOR ABOUT 1 YEAR. WE HAVE NO INFORMATION ABOUT ANY ADVERSE OUTCOME DUE TO THE ISSUE, HOWEVER WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION, THAT ANY IMPROPERLY CLEANED LOADS USED FOR PATIENTS¿ TREATMENT COULD BE THE SOURCE OF INFECTION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16458673 ↗
  • MalfunctionNov 28, 2022Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

    ON NOVEMBER 11TH, 2022 GETINGE RECEIVED AN INFORMATION ABOUT THE EVENT, WHICH WAS RELATED TO THE 86-SERIES WASHER DISINFECTOR WITH THE MODEL NAME 8668. AS IT WAS STATED, THE SAFETY LOCK OF THE TROLLEY OF THE WASHING MACHINE FELL OFF. AS A RESULT A CLEANING RACK FELL ON THE GROUND. THE SAFETY LOCK WAS REINFORCED BY THE GETINGE TECHNICIAN AND THE DEVICE AND THE TROLLEY WERE RETURNED FOR USE IN A FULLY OPERATIONAL CONDITION. THERE WAS NO ALLEGATION ABOUT ANY INJURY OR DAMAGE, HOWEVER WE DECIDED TO REPORT THE ISSUE BASED ON A POTENTIAL AS A RACK FALLING TO THE FLOOR COULD BRING A HAZARDOUS SITUATION FOR THE OPERATOR AND LEAD TO SERIOUS INJURY IF THE SITUATION WAS TO REOCCUR.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15868152 ↗
  • MalfunctionNov 3, 2022Failure to Disinfect; No Flow; Failure to Disinfect; No Flow

    ON 26TH OCTOBER, 2022 GETINGE BECAME AWARE OF AN ISSUE WITH THE 86-SERIES WASHER DISINFECTOR WITH THE MODEL NAME 8668. AS IT WAS STATED, THE CIRCULATION PUMP DID NOT RUN DUE TO THE RELAY MALFUNCTION AND THERE WAS NO ALARM ON THE DEVICE. THE MALFUNCTION DIRECTLY LED TO THE SITUATION OF IMPROPERLY CLEANED INSTRUMENTS. WE CONFIRMED THAT THE CONTAMINATED INSTRUMENTS HAVE BEEN NOTICED BY THE CUSTOMER AND THE TECHNICIAN. NEVERTHELESS, IT WAS ALSO STATED THAT THERE WAS POSSIBILITY THAT SOME UNCLEANED INSTRUMENTS HAVE BEEN RELEASED AND SHIPPED TO THE STERILIZATION PROCESS. ADDITIONALLY, WE WERE ABLE TO ESTABLISH THAT THE CUSTOMER ONLY PERFORMS RANDOM VISUAL CHECKS OF THE PROCESSED LOADS, WHICH DOES NOT COMPLY WITH THE RECOMMENDATIONS FROM THE USER MANUAL. THERE WAS NO INJURY REPORTED UNTIL THE DATE, NEVERTHELESS WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL AS NON-PROPERLY CLEANED GOODS COULD BE USED TO PATIENT TREATMENT AND COULD BE A SOURCE OF CROSS-INFECTION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15722635 ↗
  • MalfunctionOct 24, 2022Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

    MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15657262 ↗
  • MalfunctionSep 16, 2022Device Fell; Device Fell

    ON (B)(6) 2022 GETINGE RECEIVED INFORMATION ABOUT THE EVENT, WHICH WAS RELATED TO THE 86-SERIES WASHER DISINFECTOR. THE FIRST CUSTOMER ALLEGATION WAS THAT THE TROLLEY DOES NOT LOCK UP WHEN DOCKING TO THE WASHER. ON SEPTEMBER 14TH, 2022 WE RECEIVED ADDITIONAL INFORMATION THAT THE CART WITH INSTRUMENTS FELL TO THE GROUND DUE TO THE ISSUE.THERE WAS NO INJURY OR DAMAGE REPORTED, HOWEVER WE DECIDED TO REPORT THE ISSUE BASED ON A POTENTIAL AS A CART FALLING TO THE FLOOR COULD BRING A HAZARDOUS SITUATION FOR THE OPERATOR AND LEAD TO A SERIOUS INJURY IF THE SITUATION WAS TO REOCCUR.THE DEVICE WAS INSPECTED BY THE TECHNICIAN AND THE TROLLEY DOCKING MECHANISM WAS ADJUSTED AND TIGHTENED. THE DEVICE WAS RETURNED FOR USE IN FULLY OPERATIONAL STATE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15435848 ↗
  • MalfunctionJul 6, 2022Sharp Edges; Sharp Edges

    ON JUNE 30TH, 2022 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF THE WASHER-DISINFECTORS WITH THE MODEL NAME: 8668. AS IT WAS STATED, ON (B)(6) 2022, THE OPERATOR OF THE DEVICE CUT THEIR HAND ON SHARP EDGES OF THE CLEANING RACK. SO FAR, WE HAVE NOT BEEN INFORMED ABOUT ANY SERIOUS INJURY AS A CONSEQUENCE OF THE EVENT, HOWEVER WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AND BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION WAS TO REOCCUR.

    Patient problems: Skin Tears

    MAUDE report 14927994 ↗
  • MalfunctionFeb 22, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

    ON 17TH FEBRUARY, 2022 GETINGE BECAME AWARE OF AN EVENT RELATED TO THE MANUAL TROLLEY THAT WAS USED WITH THE 86-SERIES WASHER DISINFECTOR WITH THE MODEL NAME 8668. AS IT WAS STATED THE TROLLEY STOP PART THAT PREVENTS THE WASHING RACK FROM FALLING OF THE TROLLEY WAS MISSING. AS A CONSEQUENCE, THE SHELF FELL. THERE WAS NO INJURY OR DAMAGE REPORTED. NEVERTHELESS, THE FULLY LOADED SHELF FALLING ON THE GROUND COULD BRING A HAZARDOUS SITUATION FOR THE OPERATOR AND LEAD TO SERIOUS BODY INJURY IF THE SITUATION WAS TO REOCCUR, THEREFORE WE DECIDED TO REPORT THE COMPLAINT BASED ON A POTENTIAL.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13577862 ↗
  • MalfunctionDec 23, 2021Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

    ON (B)(6) 2021 GETINGE BECAME AWARE OF AN EVENT RELATED TO THE TROLLEY THAT WAS USED WITH THE 86-SERIES WASHER DISINFECTOR WITH THE MODEL NAME 8668. AS IT WAS STATED THE TROLLEY STOP PART THAT PREVENTS THE WASHING RACK FROM FALLING OF THE TROLLEY WAS BROKEN. AS A CONSEQUENCE, THE WASHING RACK ALMOST FELL. AFTER REPORTING THE EVENT, THE REPAIR WAS PERFORMED AND THE TROLLEY WAS RETURNED TO THE SERVICE IN FULLY OPERATIONAL STATE. THERE WAS NO INFORMATION PROVIDED ABOUT ADVERSE OUTCOME FOR THIS OCCURRENCE. NEVERTHELESS, THE FULLY LOADED WASHING RACK FALLING ON THE GROUND COULD BRING A HAZARDOUS SITUATION FOR THE OPERATOR AND LEAD TO SERIOUS BODY INJURY IF THE SITUATION WAS TO REOCCUR, THEREFORE WE DECIDED TO REPORT THE COMPLAINT BASED ON A POTENTIAL.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13072871 ↗
  • MalfunctionDec 17, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

    ON 14TH DECEMBER, 2021 GETINGE RECEIVED THE INFORMATION ABOUT THE EVENT WHICH WAS RELATED TO WASHER DISINFECTOR WITH THE MODEL NAME 8668. ON (B)(6) 2022 IT WAS CONFIRMED THAT THE DEVICE USED WITH THE WASHER DISINFECTOR WAS FREE STANDING UNLOADING CONVEYOR (FSUC) WHICH IS AUTOMATIC UNLOADING STATION. THE FULLY LOADED INSTRUMENT TROLLEY DROVE OFF THE FSUC AND FELL ON THE FLOOR. FURTHERMORE, IT HAS BEEN CLARIFIED THAT NO CART WAS DOCKED TO THE FSUC BEFORE THE UNLOADING WAS INITIATED. HOWEVER THE SYSTEM FAILED TO RECOGNIZE THE SITUATION AND CONSEQUENTLY ALLOWED THE UNLOADING PROCESS TO START. THE FSUC WAS TAKEN OUT OF THE SERVICE. THERE WAS NO INJURY OR DAMAGE REPORTED, HOWEVER WE DECIDED TO REPORT THE ISSUE BASED ON A POTENTIAL AS INSTRUMENTS FALLING ON THE FLOOR COULD BRING A HAZARDOUS SITUATION FOR THE OPERATOR AND LEAD TO SERIOUS BODY INJURY IF THE SITUATION WAS TO REOCCUR.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13028486 ↗

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