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

Model Number 8668

Device Problem Unintended Electrical Shock (4018)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/03/2021

Event Type  malfunction  

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 with one of our device ¿ 8666 washer disinfector.The customer alleged to sustain an electric shock when loading rack to the device.We were not informed about any adverse consequences in relation to the described situation.The getinge service technician visited the site, evaluated the device and found no malfunction that could have led to the alleged scenario.The customer site will be visited again for further analysis.No information about any injury was provided, however we decided to report this case based on the potential as received allegation is pointing to sustaining an electric shock might lead to an adverse event.

Event Description

Manufacturer reference number: (b)(4).

Manufacturer Narrative

Additional information will be provided following the conlusion of the investigation.

Manufacturer Narrative

On september 3rd, 2021, getinge became aware of an issue with one of the washer-disinfectors with the model name: 8668, with the catalog number s-86682003-ctom and the serial number (b)(6).The unit was manufactured on 26th april 2012 and installed on 27th november 2012.The reported issue is related to an electric shock.We were able to establish that this is the 2nd reportable customer product complaint related to the issue involved on this type of devices reported within the last 5 years.The customer allegation was that the employee sustained an electric shock when loading rack to the device.We were not informed about any adverse consequences in relation to the described situation.The getinge service technician visited the site, evaluated the device and found no malfunction that could have led to the alleged scenario.The body and frame of machine were tested with a digital multimeter.Electrical tests were conducted to detect voltage drops and/or spikes, no abnormalities were detected.During said test, the machine was in the exact state that it was when the incident had occurred.The machine body was then removed from both sides to expose inner wiring, mechanics, and plumbing.Nothing underneath the body coverings of the unit seemed to be tampered or out of place.There was no indication of loose wiring or connections.No breakers were tripped and no wires were burnt.Technician attempted to replicate the same actions of the customer employee, as when the event took place.Moreover, the staff demonstrated on another unit, how they typically load wash racks into the washer.No non-conformities were detected.The device was returned to use in full operational state.The result of the investigation allow us to conclude that no issues could have been found on the machine.If the machine was to give an electric shock someone there would have been active current going through the machine and there would have been faulty electronics found.The multimeters used would pick up on any of these irregularities.However, no issues were found by the technician.Based on the provided information and the fact that device was in full working condition the conclusion from the investigation is that the described electric shock was in fact a static discharge from a surface somewhere from static buildup in the room or other phenomenon that caused the sensation of a shock, however it did not come from the machine.Therefore, as no fault of the device was found, the root cause of the issue was defined as the impossible to define.Getinge does not recommend any additional activities related to the affected washer.It was confirmed that when the event occurred, the device was directly involved, however it met its specification, as no malfunction was found.When the event occurred, the device was not being used for treatment or diagnosis of the patient.We are not aware if the described issue caused or contributed to the serious injury or worse, however we report the event based on the potential for serious injury if the situation was to reoccur.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.

Event Description

Manufacturer reference number: (b)(4).

Event Description

Manufacturer reference number: (b)(4).

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.The purpose of this submission is also to provide a correction of #d4 serial and #h4 device manufacture date.This is based on the result of an internal review.Previous #d4 serial: (b)(6).Corrected #d4 serial: (b)(6).Previous #h4 device manufacture date: 2012-06-07.Corrected #h4 device manufacture date: 2012-04-26.

• 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: 12452380
• MDR Text Key: 270776266
• Report Number: 9616031-2021-00028
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 8668
• Device Catalogue Number: S-86682003-CTOM
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/03/2021
• Initial Date FDA Received: 09/10/2021
• Supplement Dates Manufacturer Received: 09/16/2021; 10/19/2021; 12/09/2021
• Supplement Dates FDA Received: 10/11/2021; 11/12/2021; 12/10/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/26/2012
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1