MAUDE Adverse Event Report: GETINGE DISINFECTION AB 8668; MEC

Model Number 8668

Device Problems Entrapment of Device (1212); Maintenance Does Not Comply To Manufacturers Recommendations (2974)

Patient Problem Laceration(s) (1946)

Event Date 04/28/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On (b)(6) 2017 technician who arrived at customer site begun an adjustment of the unloader.As it was described the technician had finger caught between unloader arm and wash rack while trying to manually push wash rack from washer chamber.As a result the technician cut middle finger of right hand that required stitches.

Manufacturer Narrative

(b)(4).We are aware that for mfr.Ref.No.9616031-2016-00013 initial report we are past the 30 day deadline for reporting.It was due to the human error.The event is being investigated.Additional information will be provided upon results of the investigation.

Manufacturer Narrative

This report is being filed under exemption e2016015 by the manufacturer getinge disinfection ab.We are aware that for mfr.Ref.No.9616031-2016-00013 initial report we are past the 30 day deadline for reporting.It was due to the human error.Getinge became aware of an event caused by a malfunctioning accessory to the medical device: an unloader.The purpose of the unloader is to facilitate unloading carts with materials from the washer disinfector device.As it was stated the operator sustained an injury during the manual unloading of the cart from this unloader.All information provided by the customer has been reviewed.It was established that the event took place as a result of a malfunction at the unloader's arm.Transfer of the goods after the washing process is performed by activation of automatic unloader and normally it does not require presence of the operator during this process.When there is no issue with the unloader the unloading arm is grabbing the wash cart from the washer disinfector and it pulls it on the transfer rolls from where it could be transferred further.In the case at hand the operator decided to unload the wash cart manually as the automatic unloading failed.Due to the misaligned height of the unloader this caused the arm to miss grabbing the wash rack and not pull it fully on the first set of conveyor belt rollers.When the operator tried to manually pull the wash rack out of the washer the unloader arm moved forward and caught operator's finger between wash cart and the unloading arm.It resulted in injury which required medical intervention by applying six stiches.When the event took place the accessory nor the washer disinfector device was not used for treatment or diagnosis.During each process the unloading arm is constantly moving, therefore it is subject to wear and tear.It is important to perform a periodical inspection of the device in order to keep it functional.Technical manual for getinge ags (504254300, rev.B) states that unloading arm should be checked every year and if necessary it should be replaced or adjusted.From information provided so far we found that the device had been installed 1,5 year before the incident occurred and no documented preventive maintenance performed during this time.Therefore we cannot rule out that a root cause of the incident is a combination of the wearing of the part and lack of the maintenance performed by the user.We believe that it the user would have followed the manufacturer recommendation the incident would have been avoided.

• Brand Name: 8668
• 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]; vaxjo, 35115 ; SW 35115
• Manufacturer Contact: dennis genito ; 45 barbour pond drive; wayne, NJ 07470 ; 9737097515
• MDR Report Key: 6632896
• MDR Text Key: 77282993
• Report Number: 9616031-2017-00013
• 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,Followup
• Report Date: 06/10/2017,09/18/2017

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: No Information
• Device Model Number: 8668
• 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: 06/10/2017
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 06/10/2017
• Initial Date Manufacturer Received: 04/28/2017
• Initial Date FDA Received: 06/11/2017
• Supplement Dates Manufacturer Received: 04/28/2017; 04/28/2017
• Supplement Dates FDA Received: 07/11/2017; 09/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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