MAUDE Adverse Event Report: GETINGE DISINFECTION AB 9027; 9000-SERIES

Device Problem Defective Component (2292)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/14/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On 14th october 2016 we become aware about an incident which occurred with one of getinge's device.It was reported by getinge representative that during inspection of cart washers, the technician had noticed that the unit had tripped during the dry phase.The getinge's technician had checked the dryer fan and he noticed that it was in bad condition.The dryer wasn't able to drew out the hot moist air from the chamber during the dry cycle.The getinge's technician informed facility staff about situation and explained that the device could run the cycle but without the drying phase there would have been hot moist air in the chamber even when the cycle had completed.After that hospital's technician who wasn't aware about the device issue went to see the device and opened the door then the hot, wet air went outside of the door of the washer.Hot water flooded the department and drenched two technicians.At the time of that event, no person was 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

An investigation was performed on this complaint.Getinge received a complaint related to 9000-series washer - disinfector where it was indicated that a sprinkler head installed at the location was activated by the hot, moist air escaped from the washer disinfector.No injury was reported due to this event.Two non-getinge technicians which were involved in the described event were drenched by the water coming from sprinkler head on the "clean" side of the device.Before the incident, the getinge 9000-series washer-disinfector was evaluated by getinge service and it was found that the drying fan malfunctioned.As found during the investigation performed by the getinge representative the facility staff was informed about device malfunction and it was clearly explained what could happened in case of the device usage before the replacement of the defective part.Therefore further use until repair by replacing drying fan was not recommended.Therefore it appears there has been a technical deficiency with the device and that directly a use error led to the event.If the facility staff had followed the user manual and the technician instruction it is considered highly probable that this event would have been avoided.In conclusion the device did not meet its specifications when the event occurred and as a result it triggered a customer-installed device that is originally intended to be a fire safety installation but was activated by accident.The device was not being used for diagnosis or treatment at the time.Based on provided information and on the results of the investigation we consider this event is a single, isolated event, which has not led to the injury, however we reported this incident in abundance of caution following initial indication of sprinklers having been set off.In hindsight the issue does not appear to be reportable.(b)(4).

• Brand Name: 9027
• Type of Device: 9000-SERIES
• 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: 6088862
• MDR Text Key: 59464228
• Report Number: 9616031-2016-00008
• 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: 11/09/2016,01/17/2017

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: Service Personnel
• 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: 11/09/2016
• Device Age: 4 YR
• Event Location: Hospital
• Date Report to Manufacturer: 11/09/2016
• Initial Date Manufacturer Received: 10/26/2016
• Initial Date FDA Received: 11/09/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/27/2012
• 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