MAUDE Adverse Event Report: GETINGE DISINFECTION AB 9100-SERIES; MEC

Model Number 9100

Device Problem Component Falling (1105)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 03/20/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Additional information will be provided following the conclusion of the investigation.

Event Description

On 20th of march 2018 getinge received the complaint about the wash carts.As stated by the customer the wash cart was improper for the containers and as a result they fell off from the wash cart.No injury was reported, however we decided to report in abundance of caution.

Manufacturer Narrative

This report is being filled under exemption e2017050 (b)(4).Investigation is currently in progress.Additional information will be provided following the conclusion of the investigation.

Manufacturer Narrative

This report is being filled under exemption e2017050 by (b)(4).Investigation is currently in progress.Additional information will be provided following the conclusion of the investigation.

Manufacturer Narrative

This report is being filled under exemption e2017050 by the manufacturer getinge disinfection ab, (registration no.9616031) on behalf of the importer getinge group logistic america, llc, (registration no.3012092534).Investigation is currently in progress.Additional information will be provided following the conclusion of the investigation.

Manufacturer Narrative

The product involved in this event is the loading equipment outside the machine (universal manifold wash cart 1300 with spray arms) that was identified with the serial number: (b)(4).This wash cart is used for cleaning/disinfection of goods gathered in the containers and intended to be used with getinge 9100-series.The affected device was installed at the customer site on 19th of february 2018.Initially, it was stated by the customer that the cart did not suit the containers they have been using and, as an effect, have not met their expectations.They have also raised their attention on the fact that the wash cart seems to be "wobbly" which in their stated opinion can cause the load to be unstable and fall as a consequence.From additional information received, we have confirmed that an incident occurred where, as stated, the containers fell of the wash cart.There was no injuries reported in relation to that instance.Unfortunately, we were not provided with an information when exactly the incident had place but, having in mind the possible weight of the container when fully loaded, we decided to report it to competent authorities in abundance of caution and based on the potential.When reviewing similar reportable events for the device family range, we have been able to establish that this complaint is a single, isolated event.From the information received we were able to establish that this particular customer uses containers from brand wagner, which has different dimensions than the most commonly used type of containers.The issue was simulated as part of this investigation: both types of containers were measured and placed the wash cart, then tilted to see if they will remain properly secured on the rack.It has been established that the height of the container that is considered to be a critical dimension for proper securing on the wash cart.As a result, the aesculap container had the correct result while the wagner container were not secure enough , giving the impression that they could fall off the wash cart.The specification given in the user manual (reference wash cart manual 6001940402 getinge 9100-series 2017-10-27 en rev.A) specifies the load length according to din standards.It also gives an information regarding the maximum dimensions of the containers that are to be used with the cart - which for the length dimension is exceeded by the wagner type container.It is worth to be noted that all potential user needs were validated and documented under validation specification documentation and that the results show that they meet the acceptance criteria with this device.To sum up, upon the performed investigation, it seems that the issue occurred due to the fact that the type and brand of containers (wagner) used by the customer is less suited, than the brand with the same din-capacity used in development of the wash cart (aesculap).Getinge disinfection ab will continue to monitor problems of this nature and will update if these should arise.The manufacturer has also informed getinge sales channel colleagues so that a reminder of this specification can be raised for awareness during the ordering process for the device with the customer, further avoiding the issue.This report is being filed under exemption e2017050 by the manufacturer getinge disinfection ab, (registration no.9616031) on behalf of the importer getinge group logistics america, llc (registration no.3012092534).

• Brand Name: 9100-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: 7439275
• MDR Text Key: 105901615
• Report Number: 9616031-2018-00004
• Device Sequence Number: 1
• Product Code: MEC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Remedial Action: Repair
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 07/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 9100
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Report Sent to FDA: 04/18/2018
• Distributor Facility Aware Date: 03/20/2018
• Event Location: Hospital
• Date Report to Manufacturer: 07/24/2018
• Date Manufacturer Received: 03/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1