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

Model Number 86668

Device Problem Component Falling (1105)

Patient Problem Laceration(s) (1946)

Event Date 08/04/2017

Event Type  Injury  

Manufacturer Narrative

This report is being filed under (b)(4) by the manufacturer getinge disinfection (b)(4) on behalf of the importer (b)(4).Additional information will be provided upon results of the investigation.

Event Description

On (b)(4) getinge became aware of an incident where one of our washer disinfector and transfer trolley were involved.As it was stated by the customer after the completed cycle in washer disinfector the operator put the wash cart on the transfer trolley and started to unloading the instruments from the cart.When unloading, the operator noticed that the cart start to fall down from the transfer trolley.When tried to reach out the trolley and avoid it to damage the operator cut the finger.After the incident the operator went to the occupational health clinic where received tetanus shot, bandage and splint.No stitches were required for this injury.

Manufacturer Narrative

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

Manufacturer Narrative

This report is being filed under exemption e2016015 by (b)(4).The event is being investigated.Additional information will be provided upon results of the investigation.

Manufacturer Narrative

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

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).Getinge received customer complaint where, as stated, due to cart falling off from the trolley an injury occurred.It has been stated that the operator of the device noticed that the cart is falling down and tried to reach the cart to prevent from further damage.Doing so the operator cut his finger.Getinge received a customer complaint where, as stated, a cart fell of from the smart trolley.Please note that smart trolley itself is not a registered medical device, however the 86-series device is registered as a medical device system.The smart trolley is an accessory manufactured by an external supplier and labeled by getinge sterilizaton ab and it can be used with a wild range of devices.This issue has been escalated to the trolley's supplier.According to the information provided by the supplier all trolleys are checked after assembly with accordance to the proper protocol.Mentioned protocol included many steps of final inspection which are to be taken before the trolley is released further.It has been established that during final testing general functionality test of the trolley is performed however the retainer ring (circlip) is not checked specifically.It has been also established that there is a possibility that during loading/unloading procedure the circlip could loosen and this may not be noticed by the customer as it is located under the trolley.The circlip is an off-the shelf component.It not taking up any force in this application.Its only purpose is to keep the bolt in place.If the grove is correct and the circlip is correctly installed it simply cannot detach by itself.It is possible that the ring was not properly installed however complaint review did not show a trend of similar complaints.As a result we cannot exclude ill-judged maintenance actions during the device lifetime.It has been established that when the event took place the device was likely not up to the manufacturer specification and it directly contributed to the outcomes of the event.It has been also established that when the event took place the device was not used for treatment or diagnosis.Given the circumstances and the fact that there is no trend observed for customer complaints with this failure mode, we shall continue to monitor further events of this nature and do not propose any further action at this time.

• 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
• MDR Report Key: 6837419
• MDR Text Key: 84335085
• Report Number: 9616031-2017-00027
• Device Sequence Number: 1
• Product Code: MEC
• UDI-Device Identifier: 07340153700277
• UDI-Public: 07340153700277
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Remedial Action: Repair
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 09/01/2017,06/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 86668
• Device Catalogue Number: S-86681003
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/01/2017
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/01/2017
• Date Manufacturer Received: 08/04/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other