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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GETINGE DISINFECTION AB 8668; MEC

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GETINGE DISINFECTION AB 8668; MEC Back to Search Results
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.
 
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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 Key6632896
MDR Text Key77282993
Report Number9616031-2017-00013
Device Sequence Number1
Product Code MEC
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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 Number8668
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/10/2017
Device Age2 YR
Event Location Hospital
Date Report to Manufacturer06/10/2017
Initial Date Manufacturer Received 04/28/2017
Initial Date FDA Received06/11/2017
Supplement Dates Manufacturer Received04/28/2017
04/28/2017
Supplement Dates FDA Received07/11/2017
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 Number1
Patient Outcome(s) Other;
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