MAUDE Adverse Event Report: GETINGE DISINFECTION AB 8668; MEC

Model Number 8668

Device Problems Detachment Of Device Component (1104); Component Falling (1105); Mechanical Jam (2983)

Patient Problem No Patient Involvement (2645)

Event Date 05/15/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On (b)(6) getinge became aware of an event where unloader connected to the washer disinfector let the cart rolling on the unloader to fall off at the end of the unloader.This happened a result of docking assembly pin being stuck in the down position, allowing cart to continue travel off the unloader.Please note that unloader itself is not a medical device however it is an accessory to washer disinfector which is registered as medical device.No injury has been reported.However we decided to report this case in abundance of caution.

Manufacturer Narrative

This report is being filed under exemption e2016015 by the manufacturer getinge disinfection ab, (registration no.9616031) on behalf of the importer getinge usa, inc., (registration no.3004147784).The malfunction occurred on unloading conveyor.This is not a medical device.It is an accessory to getinge 88-series and 86-series washer disinfector device.The conveyor loads and unloads racks with material to be disinfected, into and out of the disinfector.That it is all it does and in that way it has no effect on the core performance of the disinfector device.We have determined the medical device getinge washer disinfector has not attributed to the event and itself did not play any role of significance in the event.Getinge received customer complaint where, as stated, the cart fell down from the unloading conveyor.It was found that it was caused by the docking pin which stuck in down position while it should freeze in up position.No injury occurred as a result of complained issue only damage to the instruments placed on the cart.After the issue capa request has been raised and it resulted in capa opening.Currently capa is in state root cause analysis and pending for further steps.It was established that when the event occurred the unloader working in the system with the washer-disinfector device has not met its specification and it contributed to the event.When the event occurred the device was being used by the user.During the investigation it was found that the event occurred as a result of two factors: the program needs to be override by the pressing the reset button.The reset is done by the operator if the cart is not moved to the unloader from the washer disinfector or any other problem with the cart transferring.The end pin of the unloader needs to be stuck in the down position.When the pin is in down position there is no mechanical protection to keep the cart on the conveyor, therefore when the cart reaches the edge of the conveyor is not mechanically stopped and it falls off.It was concluded that when both of mentioned factors appear in the same time the cart could not be stopped at the end of the conveyor and could fall down on the floor.Further recommendation would be proposed after finalizing the manufacturer's investigation.

• Brand Name: 8668
• 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: ann wheeler ; 1777 e. henrietta road; rochester 14623 ; 5852725036
• MDR Report Key: 6640939
• MDR Text Key: 77729517
• Report Number: 9616031-2017-00014
• Device Sequence Number: 1
• Product Code: MEC
• UDI-Device Identifier: 07340153700277
• UDI-Public: 07340153700277
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 06/14/2017,07/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 8668
• Device Catalogue Number: S-86681003
• Device Lot Number: -
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/14/2017
• Distributor Facility Aware Date: 05/15/2017
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 05/15/2017
• Date Manufacturer Received: 05/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other