MAUDE Adverse Event Report: GETINGE DISINFECTION AB 86-SERIES; MEC

Model Number 8668

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 09/20/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Additional information will be provided upon results of the investigation.

Event Description

On (b)(6) getinge become aware of an incident where one of the devices was involved.As it was stated by the customer the unloader (which is not a medical device itself but it is attached to 86-series washer disinfector which medical device is) failed during unloading.When the incident occurred customer had to reset the unloader.As stated the only way to reset the device was to close the clean side door of the washer and open the loading side door.Therefore the customer noticed that the unloader can try to unload the washer although the unloading door is closed.There was no injury reported due to this incident, however we decided to report this case in abundance of caution.

• Brand Name: 86-SERIES
• Type of Device: MEC
• Manufacturer (Section D): GETINGE DISINFECTION AB; ljungadalsgatan 11; vaxjo kronobergs ian [se-07]; vaxjo, 35115 ; SW 35115
• Manufacturer (Section G): GETINGE DISINFECTION AB; ljungadalsgatan 11; vaxjo kronobergs ian [se-07]; vaxjo, 35115 ; SW 35115
• Manufacturer Contact: dennis genito ; 45 barbour pond drive; wayne, NJ 07470 ; 9737097515
• MDR Report Key: 6962947
• MDR Text Key: 90782672
• Report Number: 9616031-2017-00031
• Device Sequence Number: 1
• Product Code: MEC
• Combination Product (y/n): N
• Reporter Country Code: FI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8668
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/19/2017
• Distributor Facility Aware Date: 09/20/2017
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 10/19/2017
• Date Manufacturer Received: 09/20/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other