MAUDE Adverse Event Report: GETINGE DISINFECTION AB 88-SERIES; DISINFECTOR, MEDICAL DEVICES

Model Number 88-5

Device Problems Computer Software Problem (1112); Contamination /Decontamination Problem (2895); Infusion or Flow Problem (2964)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The issue is being investigated by the manufacturing site.Device not returned to the manufacturer.

Event Description

On (b)(6) 2020, getinge became aware of a customer allegation related to problems observed with detergents dosing on the washer disinfector.According to the information from the technician, no alarm occurred on the device due to the incorrect detergent dosing.Such situation could have an influence on the process efficacy and we were not able to confirm whether all loads were reprocessed in the fully working unit.There was no information provided on adverse outcome for this occurrence, however we decided to report the complaint based on a potential.

Event Description

Manufacturer reference number (b)(6).

Manufacturer Narrative

When reviewing reportable events for this type of issues we were able to establish, that the complaint was the first registered for the undetected detergent dosing issue registered on 88-series devices manufactured by getinge disinfection ab reported to company¿s complaint handling system within last 5 years.When the event occurred, the device did not meet its specification.Upon the event occurrence the device was directly involved, however it was not being used for patient treatment.The complaint was investigated by the experts from the manufacturing site who confirmed that the malfunction has shown due to the issues with software installed on the device.The software files was updated and the problem was solved.As the unit was repaired and returned to the customers¿ usage, getinge does not propose any additional activities regarding this particular device.

Manufacturer Narrative

The issue is still being investigated by the manufacturer.

Event Description

Manufacturer reference number (b)(4).

• Brand Name: 88-SERIES
• Type of Device: DISINFECTOR, MEDICAL DEVICES
• Manufacturer (Section D): GETINGE DISINFECTION AB; ljungadalsgatan 11; vaxjo
• MDR Report Key: 9686276
• MDR Text Key: 196249184
• Report Number: 9616031-2020-00005
• Device Sequence Number: 1
• Product Code: MEC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 07/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 88-5
• Device Catalogue Number: 88-303-CTOM
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1