MAUDE Adverse Event Report: GETINGE DISINFECTION AB 9100-SERIES; MEC

Model Number 9128

Device Problem Human Factors Issue (2948)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 01/11/2017

Event Type  malfunction  

Manufacturer Narrative

This report is being filed under exemption (b)(4) by the manufacturer getinge disinfection ab, (registration no.9616031) on behalf of the importer (b)(4).Additional information will be provided upon results of the investigation.

Event Description

On (b)(6) 2017 we became aware of an incident with one of our medical devices.As it was stated by the customer, the person from the night shift unloaded the washer after completed cycle and entered the washer chamber to retrieve paper debris which was noticed on the bottom of the chamber.When the user was inside the machine, its door closed.In order to open the door from the inside, the user pulled the emergency cable designed for this purpose, but the cable did not initiate door opening due to rust at the point where the cable passes through 90o fitting.To leave the washer the trapped user had to make a phone call and contact a person from on-site security to get assistance with door opening.

Manufacturer Narrative

(b)(4).The event is being investigated.Additional information will be provided upon results of the investigation.

Manufacturer Narrative

(b)(4).The event is being investigated.Suspected parts were delivered to the manufacturing site and currently tests on this parts are being performed.Additional information will be provided upon results of the investigation.

Manufacturer Narrative

(b)(4).The event is being investigated.Suspected parts were delivered to the manufacturing site and currently tests on this parts are being performed.Tests of the suspected parts are still performed by the manufacturer.Additional information will be provided upon results of the investigation.

Manufacturer Narrative

(b)(4).The event is being investigated.Suspected parts were delivered to the manufacturing site and currently tests on this parts are being performed.Tests of the suspected parts are still performed by the manufacturer.Root cause of the issue is being established.Additional information will be provided upon results of the investigation.

Manufacturer Narrative

(b)(4).Getinge became aware of an event where it was stated that after completed cycle of the 9100 series washer disinfector the person of the night shift unloaded and entered the washer chamber to retrieve paper debris which was noticed on the bottom of the chamber.When the user was inside the machine, the door of the machine has closed.The investigation on this issue has been performed.It was found that when the issue occurred at least three factors played significant role in the event: buttons of the panels were stuck and this caused delay in the communication between the panel and the main board (and in the result between the door which start closing with delay), user error as the operator entered the chamber without locking the key switch and a malfunction of the safety switch line.Note that in the case of the malfunction of the above and user error the safety switch line would normally still allow the user to escape from the chamber.User manual for getinge 9100-series (6001341202, rev.D) includes description of the controls presented on the device and an information about key switch responsibility for locking the doors door operation when switched to the lock position.The same user manual includes warning in case of entering the chamber and it states as follow: "before entering the chamber the key switch for the door operation must be switched to the lock position.Operator must keep the key while inside the chamber." in the situation when the person forgot to use key switch and is trapped in the chamber normally would be able to pull the safety wire an open the doors from inside, in the described situation the safety wire was not functioning, when pulled the door did not opened.The wire of the safety line was found rusted.When the user follows instruction for use and the device is equipped with the functional secondary safety features described malfunctions itself would not compromise user safety however the sequence of failures and the malfunction of the secondary safety line provided to the reported situation.The review of the history of the devices shows that probability of this sequence to reoccur is not likely to happen.Root cause of the failure was established as a combination of the device failures and user error as we believe if the operator would have followed the instruction included in user manual, and lockout the key switch this would have avoided this event.When the event took place the device was not used for treatment or diagnosis.At the time of the event the device was not up to specification and it contributed to the outcomes of the event.No injury was reported as a result of the incident.However we decided to report this is abundance of caution.

Manufacturer Narrative

This report is being filed under exemption e2016015 by the manufacturer getinge disinfection ab, (registration no.9616031) on behalf of the importer getinge usa, inc., (registration no.3004147784).The investigation has been performed and the potential root cause of the reported issue has been established.However the conclusions of the investigation need to be confirmed and will be presented in the final report.

• Brand Name: 9100-SERIES
• Type of Device: MEC
• 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: dennis genito ; 45 barbour pond drive; wayne, NJ 07470 ; 9737097515
• MDR Report Key: 6295846
• MDR Text Key: 66781666
• Report Number: 9616031-2017-00002
• 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,Followup,Followup
• Report Date: 01/11/2017,09/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 9128
• Device Catalogue Number: 9128-002
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Device Age: 7 YR
• Event Location: Hospital
• Date Report to Manufacturer: 01/11/2017
• Date Manufacturer Received: 01/11/2017
• 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