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

Catalog Number 9100

Device Problems Device Issue (2379); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 05/18/2017

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

Event Description

On (b)(6) getinge became aware of a sharp edges found by the customer on the wash carts used for loading the products into the washer-disinfectors.Please note that wash cart is not a medical device itself however it is an accessory to washer disinfector which is registered as medical device.No injury has been reported.Per information provided by the customer he has received 6 wash carts with the same defect.As a result in we report these six complaints separately in abundance of caution.This is report six for six.

Manufacturer Narrative

This report is being filed under exemption e2016015 (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 by the 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.(b)(4)) on behalf of the importer getinge usa, inc., (registration no.(b)(4)).Getinge received a customer complaint with indication about sharp edges found on the wash cart for 9100-series washer disinfector which could cause potential injury to the operator.There was no adverse outcome, however we decided to report this to competent authorities based on the potential and in abundance of caution.Please note that wash cart itself is an accessory and it is not registered as medical device, however washer disinfector is registered as medical device.The issue has been investigated further.It has been established that the wash carts are being supplied by an external company and the root cause of the failure is connected with final check for sharp edges on the carts.As a result of received complaints getinge decided to increase the final inspection so 100% of the products are being checked for sharp edges at the manufacturing site, before being dispatched to the final customer.In summary, when the incident occurred the device was not being used for the patient treatment or diagnosis, however it played a role in it.During the investigation it has been confirmed that the device failed to meet it specification and directly led to the event.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: 9100-SERIES WASHER DISINFECTOR
• 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: dennis genito ; 45 barbour pond drive; wayne, NJ 07470 ; 9737097515
• MDR Report Key: 6649308
• MDR Text Key: 78097970
• Report Number: 9616031-2017-00020
• 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: user facility
• Reporter Occupation: Other
• Remedial Action: Repair
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/16/2017,04/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other Caregivers
• Device Catalogue Number: 9100
• Device Lot Number: 00616
• 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: 06/16/2017
• Distributor Facility Aware Date: 05/18/2017
• Device Age: 1 MO
• Event Location: Hospital
• Date Report to Manufacturer: 06/16/2017
• Date Manufacturer Received: 05/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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