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

Model Number 88-5

Device Problem Component Falling (1105)

Patient Problem No Patient Involvement (2645)

Event Date 12/20/2016

Event Type  malfunction  

Manufacturer Narrative

During review of complaints performed on (b)(6) 2017 for one of the reportable cases we became aware of the similar issues which have been registered in our internal system in the past.As the revision of the recorded information shown that previous cases were similar we decided to report it retrospectively.The malfunction occurred on a free standing conveyor (fsc).This is not a medical device.It is an accessory to getinge (b)(4)-series and (b)(4)-series washer disinfector device.The conveyor loads and unloads racks with material to be disinfected, into and out of the disinfector.That it is all it does and in that way it has no effect on the core performance of the disinfector device.We have determined the medical device getinge washer disinfector has not attributed to the event and itself did not play any role of significance in the event.Getinge received a customer complaint where it was indicated that the rack fell off from the unloader.Cause of the issue has been recognized as missing pin on the unloader.No injury has been reported after the incident.Getinge representative who arrived on site replaced affected docking pin and concluded that the device working up to specification.It was established that when the event occurred the unloader working in the system with the washer-disinfector device has not met its specification and it contributed to the event.When the event occurred the device was being used by the user.During the investigation it was found that the event occurred as a result of two factors: the program needs an override action to be performed by the user, by the pressing the reset button.The reset is done by the operator if the cart is not moved to the unloader from the washer disinfector or any other problem with the cart transferring.The end pin of the unloader needs to be stuck in the down position.When the pin is in down position there is no mechanical protection to keep the cart on the conveyor, therefore when the cart reaches the edge of the conveyor is not mechanically stopped and it falls off.It was concluded that when both of mentioned factors appear in the same time the cart could not be stopped at the end of the conveyor and could fall down on the floor.(b)(4).

Event Description

On (b)(6) 2016 getinge received a customer complaint where it was indicated that the rack fell off from the unloader.Cause of the issue has been recognized as missing pin on the unloader.No injury has been reported after the incident.

• 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]; 35115 ; SW 35115
• Manufacturer Contact: ann wheeler ; 1777 e. henrietta road; rochester, NY 14623 ; 5852725036
• MDR Report Key: 6704315
• MDR Text Key: 80032645
• Report Number: 9616031-2017-00024
• 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 Health Care Professional
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 07/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other Health Care Professional
• Device Model Number: 88-5
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/11/2017
• Event Location: Hospital
• Date Report to Manufacturer: 07/11/2017
• Date Manufacturer Received: 06/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other