MAUDE Adverse Event Report: GETINGE DISINFECTION AB WD14 TABLO; DISINFECTOR, MEDICAL DEVICES

Model Number WD14 TABLO

Device Problems Grounding Malfunction (1271); Unintended Electrical Shock (4018)

Patient Problem Electric Shock (2554)

Event Date 02/04/2021

Event Type  malfunction  

Manufacturer Narrative

On (b)(6) 2021 getinge became aware of an event related to wd14 tablo washer disinfector.After a power failure occurrence at the facility site and upon powering the washer disinfector back up, the operator allegedly sustained a minor electrical shock.No further health consequences were reported to getinge to date.When reviewing reportable events for this type of issues we were able to establish, that the complaint is the 1st one registered on wd14 devices with the description related to alleged electric shock.When the event occurred, the device was directly involved in the reported event.However no mechanical malfunction was found on getinge device; it may somehow not have met its specification, since the cover got was alleged to have caused shock.However no failure was confirmed.Upon the event occurrence the device was not being used for patient treatment.The device affected is a 2011-produced, type wd14-tablo washer disinfector, installed on 18th january, 2012.During the investigation course, we were able to establish that the facility had previously an issue with the power supply.When the power was back, the affected device got voltage on the cover.According to the information provided, the reason of the device giving electrical shock was likely related to the grounding cable of the device, which was disconnected in the facility power box.The power box where the grounding occurs is not part of the device, or otherwise under getinge responsibility, and it is part of the facilitys infrastructure.The most likely scenario of the issue occurrence was that someone disconnected the grounding cable while performing work on electric box.After the cable re-attachment in the electrical box, the unit was put back in use working up to the manufacturer specification.We can conclude that the root cause was related to a facility issue which was most likely related to human error.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 returnd to the manufacturer.

Event Description

On (b)(6) 2021 getinge became aware of an event related to wd14 tablo washer disinfector.After a power failure occurrence at the facility site and upon powering the washer disinfector back, the operator allegedly sustained a minor electrical shock.No further health consequences were reported to getinge to date.It has been confirmed that at the time of event occurrence, the units grounding cable was disconnected and a voltage occurred on the outer cover, assessed as approximately 172v, no amperes.Due to this fact we decided to report this complaint based on the potential for a serious injury or worse, if the situation was to reoccur.

• Brand Name: WD14 TABLO
• 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: 11365704
• MDR Text Key: 266407857
• Report Number: 9616031-2021-00005
• 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: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: WD14 TABLO
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/04/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/21/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other