GETINGE 9100-SERIES 9128ERecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 07340153710061), received between Aug 13, 2021 and Jan 5, 2024 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Device Handling Problem” (6 reports).

1 FDA recall record name this device's identifier, 1 still open.

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Apr 1, 2022Open, Classified

   Inadequate documentation verifying whether device installation has been executed in accordance with the manufacturer's requirements. This can lead to installation failure modes and hazardous situations.

   Z-1078-2022 · Root cause: Other · FDA record ↗

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 5, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem

  ON DECEMBER 8TH, 2023 GETINGE BECAME AWARE OF AN ISSUE WITH THE 91E-SERIES WASHER DISINFECTOR, WITH THE MODEL NAME 9128E. AS IT WAS STATED DEBRIS WAS ON THE INSTUMENTS. THERE WAS NO ALARM ON THE DEVICE. 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 18449613 ↗
• MalfunctionDec 14, 2023Device Handling Problem; Device Handling Problem

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

  Patient problems: Muscle/Tendon Damage

  MAUDE report 18325077 ↗
• MalfunctionDec 14, 2023Device Handling Problem; Device Handling Problem

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

  Patient problems: Muscle/Tendon Damage

  MAUDE report 18325073 ↗
• MalfunctionDec 14, 2023Device Handling Problem; Device Handling Problem

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

  Patient problems: Bruise/Contusion

  MAUDE report 18325070 ↗
• MalfunctionDec 14, 2023Device Handling Problem; Device Handling Problem

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

  Patient problems: Bruise/Contusion

  MAUDE report 18325067 ↗
• MalfunctionApr 7, 2023Device Fell; Misassembly During Maintenance/Repair; Device Fell; Misassembly During Maintenance/Repair

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

  Patient problems: Bruise/Contusion

  MAUDE report 16699783 ↗
• MalfunctionDec 1, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 21ST NOVEMBER, 2022 GETINGE BECAME AWARE OF AN ISSUES RELATED TO MANUAL TROLLEY. THE MANUAL TROLLEY IS NOT REGISTERED AS A MEDICAL DEVICE, HOWEVER UPON THE SITUATION OCCURRENCE IT WAS USED WITH THE MEDICAL DEVICE WASHER DISINFECTOR WITH THE MODEL NAME 9128E. AS IT WAS STATED, THE LOADING TROLLEY ALMOST FELL ON THE FLOOR DUE TO A FAULTY STOP PIN THAT IS INSTALLED ON THE MANUAL TROLLEY TO PREVENTS THE LOADING TROLLEYS FROM FALLING OFF. THE MALFUNCTIONED PART WAS REPLACED AND THE MANUAL TROLLEY WAS RETURNED TO THE SERVICE IN FULL WORKING CONDITION. THERE WAS NO INJURY OR DAMAGE REPORTED, HOWEVER WE DECIDED TO REPORT THE ISSUE BASED ON A POTENTIAL AS LOADING TROLLEY 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 15894321 ↗
• MalfunctionMar 19, 2022Adverse Event Without Identified Device or Use Problem; Device Handling Problem; Adverse Event Without Identified Device or Use Problem; Device Handling Problem

  ON 2ND MARCH, 2022 GETINGE RECEIVED THE INFORMATION ABOUT THE EVENT WHICH WAS RELATED TO MANUAL TROLLEY UNIVERSAL WASH CART 2000 THAT IS USED WITH THE 91E-SERIES WASHER DISINFECTOR. AS IT WAS STATED ON (B)(6) 2022 AN OPERATOR REPORTED A BRUISE ON HIS FOOT DURING THE EXTRACTION OF THE INSTRUMENTS FROM THE HIGHEST SHELF OF THE TROLLEY. AFTER THE MEDICAL EXAMINATION THE OPERATOR WAS 7 DAYS OFF WORK TO RECOVER FROM THE INJURY. BASED ON THE AVAILABLE INFORMATION WE CANNOT CLASSIFY THE HEALTH IMPACT, HOWEVER WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AND BASED ON THE POTENTIAL AS WE CANNOT CONFIRM THAT SIMILAR EVENTS COULD NOT CONTRIBUTED TO THE SERIOUS INJURY IF REOCUR.

  Patient problems: Bruise/Contusion

  MAUDE report 13820059 ↗
• MalfunctionMar 19, 2022Adverse Event Without Identified Device or Use Problem; Device Handling Problem; Adverse Event Without Identified Device or Use Problem; Device Handling Problem

  ON 2ND MARCH, 2022 GETINGE RECEIVED THE INFORMATION ABOUT THE EVENT WHICH WAS RELATED TO THE MANUAL TROLLEY UNIVERSAL WASH CART 2000 USED WITH THE 91E-SERIES WASHER DISINFECTOR. AS IT WAS STATED ON (B)(6) 2021 AN OPERATOR REPORTED A STRAIN INJURY WHILE TOWING THE TROLLEY IN THE WASHING TUNNEL. THE OPERATOR REPORTED THAT THE WHEELS WERE STUCK IN THE GROOVES. AFTER THE MEDICAL EXAMINATION THE OPERATOR WAS 7 DAYS OFF WORK TO RECOVER FROM THE INJURY. BASED ON THE AVAILABLE INFORMATION WE CANNOT CLASSIFY THE HEALTH IMPACT, HOWEVER WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AND BASED ON THE POTENTIAL AS WE CANNOT CONFIRM THAT SIMILAR EVENTS COULD NOT CONTRIBUTED TO THE SERIOUS INJURY IF REOCCUR.

  Patient problems: Muscle/Tendon Damage

  MAUDE report 13820049 ↗
• MalfunctionAug 13, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  MANUFACTURER REFERENCE NUMBER: (B)(6) .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12318871 ↗