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

Model Number 88-5

Device Problems Difficult to Remove (1528); Device Operates Differently Than Expected (2913); Insufficient Information (3190)

Patient Problems Injury (2348); No Information (3190)

Event Date 03/08/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Additional information will be provided upon results of the investigation.After review of the customer information we found the customer wrongly interpreted that the device manufacturing site is getinge ic production (b)(4).While in fact the device was manufactured by getinge disinfection (b)(4).

Event Description

On 18th april 2017 getinge became aware of an incident with one of our devices.As a result of the incident an injury was alleged to have occurred.The customer who has reported the event indicated that the one of the unloaders -which is a part of washer disinfector system- for one of our 88-series washer disinfectors located at the customer site once in a while failed.This was indicated to have resulted in inconvenience for the operator who needed to pull out the racks from the washer manually.In one of those cases, when the malfunction of the unloader occurred the operator tried to pull out the rack by himself and as a result it was alleged he has injured his shoulder.No further information about the injury or injured person has been currently provided.Per information provided by the customer they have 4 unloaders with 4 washer-disinfectors installed with them.We have not been able to establish which of these four systems was involved in the alleged event.As a result, pending investigation and in the abundance of caution we report on these four devices separately.As a result despite of only one reported event, we send four reports.This is report three of four, the three other reports are (b)(4).

Manufacturer Narrative

Getinge became aware of an incident report filed out and sent to their local authority by the customer which contained an allegation about faulty equipment and injury which was indicated to have occurred as a result of the raised event.We have reached out to this customer however despite our best efforts it has transpired that the customer was not willing to share much more detail with us.Based on information available in the mentioned customer report and taking under consideration previous complaints registered for the same customer in november 2016, we can assume that there was malfunction of the unloader which is an accessory associated with the washer disinfector.Information provided in the customer report indicates that there are four washer disinfectors with associated unloaders.Despite our efforts the customer has been not able to tell us which device exactly has led to the injury and what kind of injury occurred.Therefore we are not able to establish the root cause of the failure neither the severity of the harm which occurred.We have determined the medical device getinge washer disinfector has not attributed to the event, but that the malfunction occurred on a fsuc free standing loading conveyor which is an accessory to that medical device.We have determined that this conveyor has been alleged to have malfunctioned in that it became blocked necessitating manual intervention allegedly causing the staff performing the intervention to strain themselves, and in that sense, the event is attributable to the conveyor - only.The getinge washer disinfector device itself did not play any role of significance in the event.We have not been able to establish which of these four systems was involved in the alleged event.As a result in the abundance of caution, we report on these four devices separately.As a result despite of only one reported event, we send four reports.This is report three of four, the three other reports are number 9616031-2017-00008, 9616031-2017-00009 and 9616031-2017-00011.Should at any time more information regarding this event become available, we will perform a follow-up report.However given the position the customer has taken to date, we currently consider this to be our final report on this event.(b)(4).After review of the customer information we found the customer wrongly interpreted that the device manufacturing site is getinge ic production (b)(4).While in fact the device was manufactured by getinge disinfection (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 14623 ; 5852725036
• MDR Report Key: 6571572
• MDR Text Key: 75610554
• Report Number: 9616031-2017-00010
• 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
• Report Date: 05/16/2017,06/16/2017

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: Other Caregivers
• Device Model Number: 88-5
• Device Catalogue Number: 88-303
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Report to Manufacturer: 05/16/2017
• Date Device Manufactured: 09/28/2015
• 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