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

Model Number 86-SERIES

Device Problems Component Falling (1105); Sticking (1597)

Patient Problem No Patient Involvement (2645)

Event Date 01/16/2017

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided upon results of the investigation.This report is being filed under exemption (b)(4) by the manufacturer getinge disinfection (b)(4), (registration no.9616031) on behalf of the importer (b)(4)).

Event Description

On (b)(6) 2017 we become aware of an incident with one of our devices.As it was described by the customer the switch on the free standing conveyor (fsc) did not work correctly.This switch on the end of the fsc stuck in "on" position and the cart sliding on the band of the conveyor has not been stopped.The cart full of load fell on the floor and the instruments had been damaged.

Manufacturer Narrative

(b)(4).The event is being investigated.Additional information will be provided upon results of the investigation.

Manufacturer Narrative

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

Manufacturer Narrative

(b)(4).The event is being investigated by the manufacturing site to establish a root cause of the failure.Additional information will be provided upon results of the investigation.

Manufacturer Narrative

(b)(4).The event is being investigated by the manufacturing site.Root cause of the failure is being established.Additional information will be provided upon results of the investigation.

Manufacturer Narrative

The malfunction occurred on a fsc free standing loading 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.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: 1.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.2.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.This report is being filed under exemption e2016015 (b)(4).

• 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: ann wheeler ; 1777 e. henrietta road; rochester, NY 14623 ; 5852725036
• MDR Report Key: 6329075
• MDR Text Key: 67664569
• Report Number: 9616031-2017-00003
• 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: consumer
• Reporter Occupation: Other
• Remedial Action: Repair
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/16/2017,07/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 86-SERIES
• Device Catalogue Number: 8668
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 01/16/2017
• 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