MAUDE Adverse Event Report: GETINGE DISINFECTION AB 86-SERIES; DISINFECTOR, MEDICAL DEVICES

Model Number 8668

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Skin Tears (2516)

Event Date 05/19/2021

Event Type  Injury  

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.Device not returned to the manufacturer.

Event Description

On (b)(6) 2021 getinge became aware of an issue related to 8668 washer disinfector.As it was stated, while repairing the device, the technician sustained thumb laceration required several stitches to secure the wound.The injury was classified as serious as the medical intervention was needed.

Manufacturer Narrative

On 19th may, 2021 getinge became aware of an incident which happened during a repair of 8668 washer disinfector.As it was stated, while repairing the device, the technician sustained a serious injury described thumb laceration required medical intervention by using several stitches to secure the wound.The device involved in the incident has been identified as a 8666 washer disinfector with serial number: w50047866.The unit was manufactured on 5th february, 2014.The event scenario has been defined as single isolated one on 86-series devices.During the investigation course we were able to establish, that the service technician went to the customer facility to repair the getinge device.To reach the top of the unit to replace malfunctioned part, he had to use the ladder.The ladder broke while the technician was standing on it and to avoid falling he grabbed the metal sheet placed on the wall over the device.At the time of the incident the device was not up to the manufacturer specification, however based on the incident scenario we can conclude that the cause of the injury was not directly related to the getinge device but was caused by the part of the facility construction.Nevertheless, in the service manual for 86-series devices (doc no.6002009602, rev.H) in chapter 2.3 it is stated, that the technician performing the repair of the device should always wear protective gloves, which technician did not have.To sum up, the root cause of an even was defined as a combination of several factors: broken ladder, facility issues and not following the instructions regarding protecting gloves.It was established that when the event occurred, the getinge device was not directly involved in the described incident.None of the provided information indicates that upon the event occurrence the device was being used for patient treatment.We currently do not have any information that would warrant further action towards the device manufacturing or devices on the market, however as per our complaint handling processes will continue to monitor the customer experiences with the device for any future information.There is also a correction of two fields: 1) 'manufacture date' (h4) field due to dhr document review: old h4: 02/11/2014 corrected h4: 02/05/2014.2) medical device problem code grid (h6) due to the new information received during the investigation course old h6: 3190-insufficient information corrected h6: 2993-adverse event without identified device or use problem.

Event Description

Manufacturer reference number (b)(4).

• Brand Name: 86-SERIES
• Type of Device: DISINFECTOR, MEDICAL DEVICES
• Manufacturer (Section D): GETINGE DISINFECTION AB; ljungadalsgatan 11; vaxjo
• MDR Report Key: 11906685
• MDR Text Key: 258423851
• Report Number: 9616031-2021-00012
• Device Sequence Number: 1
• Product Code: MEC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 06/22/2021

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?: Yes
• Device Operator: Other
• Device Model Number: 8668
• Device Catalogue Number: S-86682003-CTOM
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/19/2021
• Initial Date FDA Received: 05/31/2021
• Supplement Dates Manufacturer Received: 06/08/2021
• Supplement Dates FDA Received: 06/22/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention