• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GETINGE DISINFECTION AB 86-SERIES; DISINFECTOR, MEDICAL DEVICES

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

GETINGE DISINFECTION AB 86-SERIES; DISINFECTOR, MEDICAL DEVICES Back to Search Results
Model Number 8668
Device Problem Chemical Problem (2893)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/21/2021
Event Type  malfunction  
Manufacturer Narrative
Additional information will be provided following the conclusion of the investigation.Device not returned to the manufacturer.
 
Event Description
On (b)(6) 2021 getinge became aware of an issue with one of the washer-disinfectors with the model name: 8668.The first customer allegation was that the pink film was leaved on the instruments.On (b)(6) 2021 it was reported by the customer that the unit did not pass the wash check test.During the service the technician noticed issues with slow pumping of the detergent and switched detergent hoses (resulting of pumping the lubricant instead of wash detergent).The issues which were found have been fixed and the device was returned to use in fully operational state.There was no injury reported, however we decided to report the issue as we were not able to establish for how long the detergents dosing was incorrect and if the loads affected were used.Therefore, we based on the potential as the issue may affect the final result of the cleaning process and the uncleaned good may have been used to the patients treatment.
 
Manufacturer Narrative
Additional information will be provided following the conclusion of the investigation.
 
Event Description
Manufacturer reference number (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
86-SERIES
Type of Device
DISINFECTOR, MEDICAL DEVICES
Manufacturer (Section D)
GETINGE DISINFECTION AB
ljungadalsgatan 11
vaxjo
MDR Report Key12315380
MDR Text Key266408018
Report Number9616031-2021-00023
Device Sequence Number1
Product Code MEC
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Type of Report Initial,Followup
Report Date 09/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number8668
Device Catalogue NumberS-86682003-CTOM
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 07/21/2021
Initial Date FDA Received08/12/2021
Supplement Dates Manufacturer Received09/02/2021
Supplement Dates FDA Received09/27/2021
Patient Sequence Number1
-
-