MAUDE Adverse Event Report: GETINGE DISINFECTION AB FD1610; NINJO

Model Number FD1610

Device Problem Installation-Related Problem (2965)

Patient Problem Electric Shock (2554)

Event Date 12/07/2016

Event Type  Injury  

Manufacturer Narrative

We are aware that for mfr.Ref.No.9616031-2016-00009 initial report we are past the 30 day deadline for reporting.It was due to the error in processing.This report is being filed under exemption (b)(4) by the manufacturer getinge disinfection ab, ((b)(4)) on behalf of the importer (b)(6), inc., ((b)(4)).Additional information will be provided upon results of the investigation.

Event Description

On (b)(6) 2016 getinge disinfection ab received a customer complaint with the incident report were as stated, the fd1610 device caused electric shock when the technician's hand came into a contact with electrical energy source.The incident occurred during the installation of the new device.

Manufacturer Narrative

An investigation was performed on this complaint.Getinge became aware of a complaint where, as stated, our (getinge) service technician received an electrical shock during installation of the new fd1600 device at the customer site.During the installation as per normal installation routine all cables connections shall be checked and secured.It was reported that the technician has discovered disconnected cables on the electro valve for water and when he tried to re-connect it.As per information received the technician forgot to disconnect the device from main electrical supply before starting re-connection cables.The technician received an electric shock which resulted in hospitalization for 24-hours ecg, however after the clinical check the technician went back to work without day delay.When reviewing reportable events for this device we were able to establish that issue with this failure mode is considered as a single, isolated event.Compared to the number of the devices produced (about 6700 devices since 2011) the occurrence rate for reportable complaints with this failure is considered to be very low.The functionality of the device is checked at the manufacturing site during the quality control steps, as per device history file the device was properly functioning when tested at the production floor.However the cables which needed to be re-connected most probably got loose during shipment of the device, therefore it is crucial to check as per description in the technical manual if its connection is proper before the device is ready to use.Technical manual for getinge 1600-series (6001313302, rev.E) includes proper warnings therein an information about risk related to the device use when connected to the electricity supply due to the components being live: "the machine is connected to the electricity supply and some components are live" (page 37, 39, 42, 62, 63).Technical manual also contains information that before any actions are taken on the device the operator shall ensure that the device is disconnected with the main power source: "before starting work, make sure that the machine is disconnected from the electric power supply" (page 49, 53).Based on the findings and looking at outcome of the event we can conclude that proper warnings are included in the technical manual however the technician, although having a proper knowledge hasn't followed it.Based on the collected information we can assume that the device was not used for patient care or cleaning goods at the time of the event, was not up to the manufacturer specification when the event took place and was directly involved in the reportable event.The root cause of the incident is most likely connected with the error during installation of the device as the technician has not followed warnings during installation steps described in the current manuals and has not disconnected the device from the main electrical supply before his activities.When the person would follow the technical manual and disconnect the device from the main supply before his activities, the incident would have been avoided.(b)(4).

• Brand Name: FD1610
• Type of Device: NINJO
• 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: 6245017
• MDR Text Key: 64579257
• Report Number: 9616031-2016-00009
• Device Sequence Number: 1
• Product Code: FLH
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 12/14/2016,02/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: FD1610
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Report to Manufacturer: 12/14/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other