MAUDE Adverse Event Report: GETINGE DISINFECTION AB 88-SERIES; MEC

Model Number 88-5

Device Problem Component Falling (1105)

Patient Problem No Patient Involvement (2645)

Event Date 04/27/2017

Event Type  malfunction  

Manufacturer Narrative

The malfunction occurred on a fsc free standing loading conveyor.This is not a medical device.It is an accessory to getinge (b)(4)-series and (b)(4)-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.On (b)(6) getinge received a customer complaint with following description: "pulling arm hitting clean side door and once carriage is on unloading table keeps going and off the other side onto floor.Docking pins keeps getting bent and causing to jam into unload position.However we have now replaced these docking pins to both unloader 2/3 times on each.Plus report pulling arm to (b)(6) technical department, as seem to be software issue." the record registered in trackwise system was registered for the same device which had been complained before (#(b)(4)) where it was stated that the docking pin failed and it resulted in cart falling down.This issue has been reported to competent authorities.Our current case (b)(4) - autoloaders - unload load carriage from turbo washer (b)(4) was not initially reported as the description in the complaint record suggested that it is a report of the repair done after the evert registered in the previous complaint (b)(4), on (b)(6) 2017 we got an information that this were 2 separate events.Therefore we report this case retrospectively with the awareness date of (b)(6) 2017.No injury has been reported as a result of described malfunction.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 an override action to be performed by the user, 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.(b)(4).

Event Description

On (b)(6) getinge received a customer complaint with following description: "pulling arm hitting clean side door and once carriage is on unloading table keeps going and off the other side onto floor.Docking pins keeps getting bent and causing to jam into unload position.However we have now replaced these docking pins to both unloader 2/3 times on each.Plus report pulling arm to (b)(6) technical department, as seem to be software issue.".

• Brand Name: 88-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]; 35115 ; SW 35115
• Manufacturer Contact: ann wheeler ; 1777 e. henrietta road; rochester, NY 14623 ; 5852725036
• MDR Report Key: 6704324
• MDR Text Key: 80043288
• Report Number: 9616031-2017-00025
• Device Sequence Number: 1
• Product Code: MEC
• 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 Health Care Professional
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 07/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other Health Care Professional
• Device Model Number: 88-5
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/11/2017
• Event Location: Hospital
• Date Report to Manufacturer: 07/11/2017
• Date Manufacturer Received: 06/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other