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

Model Number 9128

Device Problem Fracture (1260)

Patient Problems Burn(s) (1757); Partial thickness (Second Degree) Burn (2694)

Event Date 06/24/2022

Event Type  malfunction  

Event Description

On 23rd june, 2022 getinge became aware that the 91-series washer disinfector was not working properly.As the information was not safety related we decided not report the event to the competent authority.On 24th june, 2022 during service of the unit the technician was burned on the right side of the back by condensate that has 93°c.After the event the hospital took care of the technician.No further health consequences were reported to date.Based on the available information we cannot classify the health impact, however we decided to report the issue in abundance of caution and based on the potential as we cannot confirm that similar events could not contributed to the serious injury if reocur.

Manufacturer Narrative

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

Manufacturer Narrative

According to the reporting timeframe we would like to provide the information about current status of the issue.Please be advised that it is being investigated.Additional information will be provided following the conclusion of the investigation.The purpose of this submission is also to provide corrections of the sections b3.Date of event, b5.Describe event or problem and h6.Adverse event problem - patient code.B3.Date of event.Previous provided: 2022-06-23.Corrected: 2022-06-24.B5.Describe event or problem.Previous provided: on 23rd june, 2022 getinge became aware that the 91-series washer disinfector was not working properly.As the information was not safety related we decided not report the event to the competent authority.On 24th june, 2022 during service of the unit the technician was burned on the right side of the back by condensate that has 93°c.After the event the hospital took care of the technician.No further health consequences were reported to date.Based on the available information we cannot classify the health impact, however we decided to report the issue in abundance of caution and based on the potential as we cannot confirm that similar events could not contributed to the serious injury if reoccur.Corrected: on 23rd june, 2022 getinge became aware that the 91-series washer disinfector was not working properly.As the information was not safety related we decided not report the event to the competent authority.On 24th june, 2022 during service of the unit the technician was burned on the right side of the back by condensate that has 93°c.After the event the pharmacist and the hospital staff took care of the technician and provided first aid.On 29th july, 2022 we received information that the burn was classified as 2nd degree burn.Based on the available information we decided to report the issue based on the potential as we cannot confirm that similar events could not contribute to the serious injury if reoccur.H6.Adverse event problem - patient code.Previous provided: 1757.Corrected: 2694.

Event Description

Manufacturer reference number: (b)(4).On 23rd june, 2022 getinge became aware that the 91-series washer disinfector was not working properly.As the information was not safety related we decided not report the event to the competent authority.On 24th june, 2022 during service of the unit the technician was burned on the right side of the back by condensate that has 93°c.After the event the pharmacist and the hospital staff took care of the technician and provided first aid.On 29th july, 2022 we received information that the burn was classified as 2nd degree burn.Based on the available information we decided to report the issue based on the potential as we cannot confirm that similar events could not contribute to the serious injury if reoccur.

Event Description

Manufacturer reference number: (b)(4).

Manufacturer Narrative

Getinge became aware on 23rd june, 2022 about an event with a washer disinfector from 91-series that took place on the same day.The customer reported problem with ¿a03¿ error displayed on the unit.During troubleshooting the technician burned his back with the condensate from a damaged pipe.We established that condensate from the damaged pipe directly contributed to the adverse event, which took place on 24th june, 2022.Based on initial information there was a skin burn, therefore we decided to report the case in abundance of caution as this kind of malfunction could lead to serious injury.The involved device was identified to carry serial number: (b)(6) and catalog number: 9128-ctom.Manufacture date of the device is 19th may, 2010.The mentioned unit is under getinge maintenance and as it was confirmed the last service was carried out on 28th april, 2022.As a result of performed investigation we could establish that the most probable root cause of the event occurred as a result of combination of two factors: ¿ leakage from damaged pipe is related to expected wear and tear.The problem has been resolved by the replacement of the pipe.¿ the burn occurred as a result of not paying appropriate attention by technician during troubleshooting.When the event occurred, the device was directly involved and did not meet its specification (damaged pipe).Upon the event occurrence the device was not being used for patient treatment.After the investigation course we were also able to confirmed that this is the first issue connected with this type of malfunction.When reviewing similar reportable events for the same device type, we have been able to confirm that the investigated issue has never led to serious injury or worse, to our knowledge.We currently do not have any information that would warrant further action towards the device manufacturing or devices on the market, however getinge will continue to monitor the customer experiences with the device for any future information.The purpose of this submission is also to provide a correction of the field h4.Device manufacture date previous provided h4.Device manufacture date: 2010-05-24.Corrected h4.Device manufacture date: 2010-05-19.

• Brand Name: 91-SERIES
• Type of Device: DISINFECTOR, MEDICAL DEVICES
• Manufacturer (Section D): GETINGE DISINFECTION AB; ljungadalsgatan 11; vaxjo
• Manufacturer (Section G): GETINGE DISINFECTION AB; ljungadalsgatan 11; vaxjo
• Manufacturer Contact: dennis genito ; ljungadalsgatan 11; vaxjo
• MDR Report Key: 14885800
• MDR Text Key: 295153093
• Report Number: 9616031-2022-00015
• Device Sequence Number: 1
• Product Code: MEC
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 9128
• Device Catalogue Number: 9128-CTOM
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/05/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/19/2010
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male