MAUDE Adverse Event Report: GETINGE DISINFECTION AB 88-SERIES; DISINFECTOR, MEDICAL DEVICES

Model Number 88-5

Device Problem Unintended Electrical Shock (4018)

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

Event Date 10/07/2022

Event Type  malfunction  

Event Description

On october 27th, 2022 getinge became aware of an issue with the 88-series washer-disinfector with the model name: 88-5.The reported event took place on (b)(6) 2022.It was directly reported by the facility to the mpa (swedish medical products agency) and registered under report number: (b)(4).As it was stated the customer's technician worked with the troubleshooting and adjustments of the device and accessed live equipment.In more details, when the engineer was adjusting the microswitches for door locking with live device, the electrical cover was removed / open, and he got in contact with live voltage inside and behind safety restrictions.He had a direct or indirect contact with the screwdriver he used.The engineer stated that he was not injured, however we decided to report this case based on the potential for a serious injury if the situation was to reoccur.

Manufacturer Narrative

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

Event Description

Manufacturer's reference number: (b)(4).

Manufacturer Narrative

On october 27th, 2022 getinge became aware of an issue with the 88-series washer-disinfector with the model name: 88-5.The reported issue is related to electric shock.Trend review of customer product complaints with the same issue involved on this type of device reported within the last 5 years was performed but did not provide any signals that would warrant further scrutiny.The result of this investigation allows us to conclude that problem is a consequence of a third party installer not following the device¿s instruction manuals and not isolating the machine from the incoming electrical supply.As a result the customer¿s technician has received electric shock.Therefore, we were able to establish the event is related to the third party service.We are not aware if the described issue caused or contributed to any serious injury or worse, however we report the event based on the potential of serious injury if the situation was to reoccur.In summary, when the event occurred, the device seized to meet its specification and it contributed to the event.In the time when the event occurred, the device was not being used for patient treatment.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 at this time.Based on the result of an internal review noting the report did not contain available information we provide a correction of section h.#h4: previous h4: 26-04-2010, corrected h4: 13-04-2010.

• Brand Name: 88-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: 15722311
• MDR Text Key: 307213486
• Report Number: 9616031-2022-00023
• Device Sequence Number: 1
• Product Code: MEC
• Combination Product (y/n): N
• Reporter Country Code: SW
• 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
• Report Date: 11/03/2022

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 Operator: Other
• Device Model Number: 88-5
• Device Catalogue Number: 88-303-CTOM
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/27/2022
• Initial Date FDA Received: 11/03/2022
• Supplement Dates Manufacturer Received: 10/20/2023
• Supplement Dates FDA Received: 10/27/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/13/2010
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1