MAUDE Adverse Event Report: GETINGE DISINFECTION AB SMART TROLLEY

Model Number 6020720171

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Date 02/01/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).We are aware that we are past the 30 day deadline for reporting.Initial information did not provide any information that made it apparent to conclude that this type of event could resulted in e.G.Serious injury, however further review showed that there is a possibility for this kind of event to occur.When reviewing reportable events for the smart trolleys we were able to confirm that this is the 3rd reportable complaint where the issue with an issue with the distal pin part is being raised in the getinge complaint handling system.Although there was no adverse outcome raised for the complaint, it was decided to be reportable to competent authorities based on the performed review.In accordance to the review we have concluded that malfunction of the end pin has led to the serious injury occurrence in the past (a cart fell off the trolley due to the malfunctioning end pin and caused a cut on the operator's hand that required a medical intervention, thus was classified as serious injury) therefore all complaints covering this type of malfunction shall be considered as reported to competent authorities.Please note that smart trolley itself is not a registered medical device.The smart trolley is an accessory manufactured by an external supplier and labeled by getinge sterilization ab and it can be used with a wide range of medical 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.

Event Description

Getinge received customer complaint with an indication about broken distal pin.As it was stated by the customer the distal pins that stop the wash cart from moving forward are too flimsy and break easily.No injury has been reported due to complained situation, however we decided to report this case in abundance of caution.

• Brand Name: SMART TROLLEY
• Type of Device: SMART TROLLEY
• 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: dennis genito ; 45 barbour pond drive; wayne, NJ 07470 ; 9737097515
• MDR Report Key: 7666205
• MDR Text Key: 113310069
• Report Number: 9616031-2018-00005
• Device Sequence Number: 1
• Product Code: MEC
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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
• Report Date: 07/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 6020720171
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/06/2018
• Distributor Facility Aware Date: 02/01/2018
• Device Age: 3 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/06/2018
• Date Manufacturer Received: 02/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/11/2016
• 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