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

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

Patient Problems Bruise/Contusion (1754); Swelling (2091)

Event Date 06/15/2016

Event Type  Injury  

Manufacturer Narrative

The getinge ags loading equipment is an accessory to getinge 8668/88 - series washer-disinfectors.The serial number of the accessory was (b)(4).The washer serial number the loading equipment was used with has not been provided.The injured person was given first aid treatment but did not require any additional medical attention.She was advised to put ice on her hand as needed to minimize the swelling and she received 2 days off due to her discomfort.The injured person was a facility technician.Note: the getinge 8666 washer disinfector and the getinge ags accessory are sold to both healthcare and non-healthcare environments, in this case the device was used in a non-healthcare application.The getinge ags loading and conveyor equipment is designed as an automatic conveyor system for load carriers (wash carts) for getinge 8668/88 - series washer-disinfectors.The conveyor track handles the loading and unloading of wash carts with soiled or disinfected items.A wash cart is placed on the conveyor track and is automatically loaded into the first available washer-disinfector.When the items are fully processed and disinfected, the wash cart is ready to be unloaded and transferred to the shuttle.The fully automatic ags conveyor tracks are run via a number of sensors.After the incident, the getinge ags loading equipment was evaluated by (b)(4) service and no malfunction was found.(b)(4) service inspected operation of both, the washer and the ags equipment and checked proximity sensors.The washer and the ags system were thoroughly tested and as stated all were operating as designed.The issue was discussed with the facility medical maintenance personnel, end user and supervisors.The end users were reminded to call in a work order to medical maintenance in the event of any issues with their equipment.End users have been advised to remain clear of the area in which the ags shuttle travels and never attempt to clear or free any trolley, shuttle, or equipment that is stuck, activate the equipment e-stop and contact their supervisor.As found in the user manual for getinge ags loading equipment (getinge ags user manual 6001299402): "operating instructions: 3.5 alarms: the conveyor track stops if an alarm is activated.Check which alarm is active.If the blue lamp at the far right of the electrical cabinet is lit, there is an error on the loading side.If the blue lamp at the far left of the electrical cabinet is lit, there is an error on the unloading side.This applies if the emergency stop is activated; correct the error if possible; acknowledge the alarm by pressing once; press the reset button once and the conveyors will continue to transport from the position in which they were stopped; other errors must be acknowledged via the operator panel; after acknowledging the error, press the start button."(page 24) "safety: 1.3 users and environment; 1.3.6 crushing risk; beware of the risk of crushing due to the machine's moving parts." (page 9) the end users tried to correct trolley position, that was wrong and caused the alarm, and cleared the alarm simultaneously instead of following the action sequence as recommended in the manual.As a result the device moved, the person correcting the position was pushed against the other nearby standing equipment and pinched.Regardless the alarm type, the correction of the error which caused the machine to stop should be performed prior to acknowledging the alarm.Therefore it appears there has been no technical deficiency with the device and that a use error led to the event.The most relevant use error is lack of caution and not following warnings provided in user manual.If the user manual would have been followed it is considered highly probable that this event would have been avoided.

Event Description

On june 15, 2016 (b)(4) received a customer complaint with an incident report where as stated, a person was injured after being pinched by getinge ags (accessory automatic loading equipment) used with getinge model 8666 washer disinfector and suffered from major bruising to her left hand, as well as bruising to her left hand tendons, with physical pain and discomfort.

• 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, 35115 ; SW 35115
• MDR Report Key: 5800362
• MDR Text Key: 49757236
• Report Number: 3004147784-2016-00002
• 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: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/15/2016
• Device Age: 5 YR
• Event Location: Other
• Date Report to Manufacturer: 06/15/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/16/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 35 YR
• Patient Weight: 98