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

Model Number 8668

Device Problems Detachment Of Device Component (1104); Component Falling (1105); Material Frayed (1262)

Patient Problem No Patient Involvement (2645)

Event Date 09/05/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On 5th september 2016 getinge become aware of the event which occurred on the one of the getinge's 86-serie washer disinfector.It was reported by the getinge representative that a wire from the door opening mechanism has ruptured and the door of the washer disinfector felt down.The device was inspected at the customer site and it was found that a microswitch which activates door motor to coil the wire onto a roller to open the door did not switch off the motor, therefore the motor continued to work providing to wire stretch.In the result of the extensive force the wire ruptured and the door fall down.It has to be noted that the doors of the 86-series washers are placed on the two wires.In this case one of them fractured and the second become loose due to damage of the wire clamp.Combination of this two failures provided to the door falling.At the time of that event no person was involved or injured although we report this case in abundance of caution as we see a risk for a user when the situation was to reoccur.

Manufacturer Narrative

Getinge received a complaint related to a 86-series washer - disinfector where it was indicated that the wire from the door opening mechanism had ruptured and the door of the washer disinfector had accidently fallen down to its lowest position.The device was inspected at the customer site by the getinge representative and it was found that a microswitch which activates a door motor (to coil the wire onto a roller in order to open the door) did not switch off the motor, therefore the motor continued to work until it uncoiled the wire.As a result of the extensive force, the wire ruptured and the door fell down to its lowers position.It has to be noted that the doors of the 86-series washers are placed on two wires.In this case one of them ruptured and the second became loose due to damage of the wire clamp.It was the combination of this two failures caused the door to fall.Further investigation showed that very often an error showing "cs door" appeared in the display.This gives us indication that before the incident happened where the wire ruptured and the door has fallen, the machine was giving signals that there is something wrong with the door mechanism.User manual for 86-series washer-disinfector (6001300302, rev.E) provide information about proper maintenance of the device.It clearly states that the door switch of the machine must not be bypassed.If the mentioned error appears often on the display the end user should contact with the service.From information provided by the originator none of the reports were declared by the customer.Summing up the described circumstances, the most likely root cause of the failure was user not following the instructions given in the manual.Furthermore technical manual for 86-series washer-disinfector (6001300602, rev.E) describes steps which should be taken during the preventive maintenance (pm) of the device and it clearly states that door switch adjustment is needed and could be done only by a qualified person.During the pm the qualified technician should check the signals from all switches to the control system by reading relevant diodes on i/o module.Positions of all switches are indicated with codes for each piece of equipment and the way how it should be adjusted is described.The service table presented in technical manual provide information about frequency of preventive maintenance for each part.In the case of the door its adjustment should be made every year or every 4000 cycles.Review of the previous cases was performed and it was established that over the total number of the 86-series washers-disinfectors sent since 2006 to the end of 2012 ((b)(4) since the beginning of 2006), we can see this case as a single and isolated event.The device was not being used with a patient, it did not cause any event involving a person but played a role in the complaint, and it was found to be out of specification.We believe that if the user was following the instruction given in the manuals, in particular performing proper maintenance of the machine and would act accordingly when the error occurred, the malfunction of the device could be found earlier and the incident would have been avoided.Based on the provided information and on the results of the investigation we consider the incident as a single isolated incident, with low risk of reoccurrence as it needs a series of errors to occur.These errors that are mitigated and therefore there also needs to be a use error present to circumvent the mitigation, however we report this incident in abundance of caution.(b)(4).

• Brand Name: GETINGE 86 SERIES WASHER DISINFECTOR
• Type of Device: MEC
• Manufacturer (Section D): GETINGE DISINFECTION AB; ljungadalsgatan 11; vaxjo kronobergs ian [se-07]; vaxjo, sweden 35115 ; SW 35115
• Manufacturer (Section G): GETINGE DISINFECTION AB; ljungadalsgatan 11; vaxjo kronobergs ian [se-07]; vaxjo, sweden 35115 ; SW 35115
• Manufacturer Contact: ann wheeler ; 1777 e. henrietta road; rochester, NY 14623 ; 5852725036
• MDR Report Key: 5998986
• MDR Text Key: 56448160
• Report Number: 9616031-2016-00004
• Device Sequence Number: 1
• Product Code: MEC
• Combination Product (y/n): N
• Reporter Country Code: HU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 10/04/2016,11/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 8668
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 09/05/2016
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 10/04/2016
• Date Manufacturer Received: 09/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/10/2014
• 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