MAUDE Adverse Event Report: GETINGE DISINFECTION AB 91-SERIES; DISINFECTOR, MEDICAL DEVICES

Model Number 9120

Device Problem Failure to Align (2522)

Patient Problem Bone Fracture(s) (1870)

Event Date 08/11/2020

Event Type  Injury  

Manufacturer Narrative

Issue is being investigated by manufacturing site.Device not returned to manufacturer.

Event Description

On 18th august, 2020 getinge became aware of an issue with 91-series washer disinfector.As it was stated, staff member had injured herself while removing the cart from washer and sustained vertebra t7 crush fracture.Additional information received august 27 2020-the staff member attended the emergency department and was kept in overnight.She is being treated by her doctor and is currently on a sick leave.Ref: (b)(4).

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.There is a correction of the field 'manufacture date' (h4) due to the review of the documents provided by the manufacturing site: previos date: 08/28/2014.Corrected date 08/19/2014.

Event Description

Manufacturer reference number (b)(4).

Manufacturer Narrative

From the information collected to the date, we know that the guide rails intended to guide the movement of cart were out of alignment.The same issue was discovered on the device by the getinge technician on the previous visit.During that visit before the event, the getinge technician corrected the rail and instructed the staff member to follow the instructions about installation and alignment of the part given in the installation manual of the device.He also showed the staff member how to properly adjust the part.Unfortunately after the event, the same part was found reinstalled incorrectly and the fact was established as a root cause of cart blocking.It was not established who from the facility staff could perform the alignment work on the device.The fact that contributed to the unfortunate accident was concluded most likely as facility technician error.The device did not meet its specification however, in the time the event occurred, it was not being used for patient treatment or diagnosis.After the event occurrence, the getinge technician organized the meeting and one more time instructed all the staff how to handle the device properly.Given the findings of this investigation getinge shall continue to monitor for any further events of this nature and does not propose any other action related to the device at this time.

Event Description

Manufacturer reference number: (b)(4).

• Brand Name: 91-SERIES
• Type of Device: DISINFECTOR, MEDICAL DEVICES
• Manufacturer (Section D): GETINGE DISINFECTION AB; ljungadalsgatan 11; vaxjo
• MDR Report Key: 10476391
• MDR Text Key: 205100320
• Report Number: 3012092534-2020-00002
• Device Sequence Number: 1
• Product Code: MEC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup,Followup
• Report Date: 11/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9120
• Device Catalogue Number: 9120-001-CTOM
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/16/2020
• Distributor Facility Aware Date: 10/28/2020
• Device Age: 5 YR
• Event Location: Hospital
• Date Report to Manufacturer: 11/16/2020
• Date Manufacturer Received: 10/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention