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

Model Number 8666

Device Problem Unintended Electrical Shock (4018)

Patient Problem Electric Shock (2554)

Event Type  malfunction  

Manufacturer Narrative

On 30th june 2021 getinge became aware of an event related to 86-series washer disinfector.During the device repair, the getinge service technician was testing the devices valves by using the multi meter.At the same time his other hand remained on the device.As a consequence it is alleged that the service technician received an electric shock, and had to be examined afterwards.We are however not aware about any adverse consequences resulting from to this situation.Nevertheless, we decided to report this complaint to competent authorities based on the potential for adverse consequences related to an electric shock.When reviewing reportable events for this type of issues we were able to establish, that the complaint is the 1st one registered on 86-series devices with the description related to electric shock.When the event occurred, the device was directly involved in the reported event.However it did meet its specification and no mechanical malfunction was found on getinge device that could have resulted in the electrical defect.The device was not being used for patient treatment.The device affected is a 2003-produced, type 8666 washer disinfector.During the investigation course, we were able to establish that while the multi meter probe touched the valve of the powered device, the surge went through the hand via the probe in to the body.This would not happen if the multi-meter was used by only touching the parts of the machine that was being measured with the two probes of the multi-meter since it has a built in surge protection fuse in order to protect the technician from the risk of shock.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.Device not returned to the manufacturer.

Event Description

On 30th june 2021 getinge became aware of an event related to 86-series washer disinfector.During the device repair, the getinge service technician was testing the devicess valves by using the multimeter.At the same time his other hand remained on the device.As a consequence he alleged to receive an electric shock and he had to be examined afterwards.We are however not aware about any adverse consequences due to this situation.Nevertheless, we decided to report this complaint to competent authorities based on the potential for adverse consequences related to an electric shock.

Manufacturer Narrative

The correction of b5 "describe event or problem" field deems required.This is based on the internal evaluation.Previous: on 30th june 2021 getinge became aware of an event related to 86-series washer disinfector.During the device repair, the getinge service technician was testing the devices¿s valves by using the multimeter.At the same time his other hand remained on the device.As a consequence he alleged to receive an electric shock and he had to be examined afterwards.We are however not aware about any adverse consequences due to this situation.Nevertheless, we decided to report this complaint to competent authorities based on the potential for adverse consequences related to an electric shock.Corrected b5: on 30th june 2021 getinge became aware of an event related to 86-series washer disinfector.During the device repair, the getinge service technician was testing the devices¿s valves by using the multimeter.At the same time his other hand remained on the device.As a consequence he alleged to receive an electric shock and he had to be examined afterwards.We are however not aware about any adverse consequences due to this situation.Nevertheless, we decided to report this complaint to competent authorities based on the potential for adverse consequences related to an electric shock.Furthermore on 10th august, 2021 after the conclusion from the investigation was shared with the technician it was provided that the used equipment was pool finder/ measuring stick not the multimeter.Additional information will be provided following the conclusion of the investigation.

Event Description

On 30th june 2021 getinge became aware of an event related to 86-series washer disinfector.During the device repair, the getinge service technician was testing the devices¿s valves by using the multimeter.At the same time his other hand remained on the device.As a consequence he alleged to receive an electric shock and he had to be examined afterwards.We are however not aware about any adverse consequences due to this situation.Nevertheless, we decided to report this complaint to competent authorities based on the potential for adverse consequences related to an electric shock.Furthermore on 10th august, 2021 after the conclusion from the investigation was shared with the technician it was provided that the used equipment was pool finder/ measuring stick not the multimeter.

Manufacturer Narrative

On 30th june 2021 getinge became aware of an event related to 86-series washer disinfector.The reported issue is related to an electric shock.We were able to establish that this is the first reportable customer product complaint in which the allegation about the electric shock involved on this type of devices reported within the last 5 years was confirmed.The device affected is a 2003-produced, type 8666 washer disinfector.During the investigation course, we were able to establish that the customer alleged the water leakage from the device.The hazardous situation took place while the getinge technician was performing a repair on the involved device related to a water leakage.The water was leaking from the machine onto the chassis plates and other parts assembled inside of the device.The technician conducted all necessary repairs and replacements, turned the device on and attempted to measure the current of the solenoid valve using elma volt test 106 - voltage indicator (the equipment indicates ac voltage without the need of touch).At the same time his other hand remained on the device.As some parts of the device remained wet and the machine was in `on` state, the water conducted the electricity from the pump to the chassis and then to the hand of the technician hand who had touched the cover during the measurement.Performed investigation allowed us to establish that the root cause for the hazardous situation occurrence is related to a human error as although the getinge technician is a trained electrician and is used to perform measurements on the live devices in this particular case he did not foresee electrocution hazard and did not follow the instructions and warnings given by the manufacturer in the service manuals and device labeling.When the event occurred, the device was directly involved in the reported event.It was established that the device did not meet its specification as the leakage of the water occurred and together with an occurrence of the human error created a hazardous situation related to an electric shock.The device was not being used for patient treatment.We believe that devices in the market are performing correctly overall.However, as per our complaint handling processes 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 section `h6.Adverse event problem` provided in the initial report.This is due to the new conclusion from the performed investigation provided in the section `h10.Addtl mfg narrative/corr.Data` of this report.`investigation findings` codes provided in the initial report: 115 - maintenance problem identified.213 - no device problem found.Corrected `investigation findings` code: 115 - maintenance problem identified.`component codes` code provided in the initial report: 423 - electrical and magnetic|cable, electrical.Corrected `component codes` code: 772 - mechanical cover.`investigation conclusions` codes provided in the initial report: 51 - cause traced to maintenance.18 - cause traced to user|failure to follow instructions.27 - cause traced to training.Corrected `investigation conclusions` codes: 51 - cause traced to maintenance.18 - cause traced to user|failure to follow instructions.

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
• Manufacturer (Section G): GETINGE DISINFECTION AB; ljungadalsgatan 11; vaxjo
• Manufacturer Contact: dennis genito ; ljungadalsgatan 11; vaxjo
• MDR Report Key: 12196119
• MDR Text Key: 266407433
• Report Number: 9616031-2021-00019
• Device Sequence Number: 1
• Product Code: MEC
• Combination Product (y/n): N
• Reporter Country Code: DA
• 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: 12/14/2021

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?: No
• Device Model Number: 8666
• Device Catalogue Number: S-8666913-CTOM
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/30/2021
• Initial Date FDA Received: 07/20/2021
• Supplement Dates Manufacturer Received: 08/10/2021; 12/03/2021
• Supplement Dates FDA Received: 09/03/2021; 12/14/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 43 YR
• Patient Sex: Male
• Patient Weight: 78 KG