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

Model Number 88-SERIES

Device Problems Component Falling (1105); Device Operates Differently Than Expected (2913)

Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)

Event Date 05/03/2017

Event Type  malfunction  

Manufacturer Narrative

This report is being filed under exemption (b)(4) by the manufacturer getinge disinfection ab, (registration no.9616031) on behalf of the importer getinge usa, inc., (registration no.3004147784).Additional information will be provided upon results of the investigation.

Event Description

On (b)(6) 2017 getinge became aware of an incident with one of our devices.As it was stated by the customer after the end of the cycle the cart from washer disinfector was transferred by the automatic unloader to the clean side.As normally the cart should have stopped at the end of the unloader but it did not happen.The cart did not stop when reached end of the unloader and as a result it fell down with all instruments placed on the cart.Falling instruments hit the operator who has been working at nearby station.

Manufacturer Narrative

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

Event Description

On 3rd may 2017 getinge became aware of an incident with one of our device.As it was stated by the customer after the end of the cycle the cart from washer disinfector was transferred by the automatic unloader to the clean side.As normally the cart should stopped at the end of the unloader but it did not happen.The cart did not stop when reached end of the unloader and as a result it fell down with all instruments placed on the cart.Falling instruments hit the operator who has been working at nearby station.

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 a customer complaint where, as stated by the customer, after the end of the cycle the cart from washer disinfector was transferred by the automatic unloader to the clean side.As normally the cart should stop at the end of the unloader but it did not happen.The cart did not stop when reached end of the unloader and as a result the cart fell down on the floor with all instruments placed on it.Falling instruments hit the operator who has been working at nearby station.The member of staff has not sustained any serious injury and has not required any medical intervention beside being frightened.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.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: 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]; vaxjo, 35115 ; SW 35115
• Manufacturer Contact: ann wheeler ; 1777 e. henrietta road; rochester, NY 14623 ; 5852725036
• MDR Report Key: 6571579
• MDR Text Key: 75526343
• Report Number: 9616031-2017-00012
• Device Sequence Number: 1
• Product Code: MEC
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,user facility
• Reporter Occupation: Other
• Remedial Action: Repair
• Type of Report: Initial,Followup,Followup
• Report Date: 05/17/2017,07/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 88-SERIES
• 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: 05/17/2017
• Distributor Facility Aware Date: 05/03/2017
• Event Location: Hospital
• Date Report to Manufacturer: 05/17/2017
• Date Manufacturer Received: 05/03/2017
• 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