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

Model Number 9120

Device Problem Circuit Failure (1089)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/14/2019

Event Type  malfunction  

Manufacturer Narrative

Getinge received customer product complaint where 9128 device the boiler overheated however there was no fire occurrence.The customer alleged that the thermal fuse has not done the job.Firefighters were called in as smoke was present and the area evacuated.Following firefighter information, the temperature on the boiler surface reached 165°c.According to the pictures provided by the customer, the fuse has popped out so it played its role.The device wasn¿t up to manufacturer¿s specification and it contributed to the issue.In the time when the event occurred the device was not being used for the patient treatment.As a result of the issue investigation the risk evaluation was updated and shows that the possible outcome may have lead to a permanent injury, even although this did not take place.The issue was raised to the factory; it appeared that it is obvious installation error as incorrect cables were mounted while installation of the device.To sum up, the issue is related to wrong installation at customer¿s facility.We believe that overall our devices are performing correctly on the market.

Event Description

On 14th october, 2019 getinge received customer product complaint where 9128 device the boiler overheated and there was no fire occurrence.Customer alleged that the thermal fuse has not done the job.Firefighter has been engaged as smoke was present and the area evacuated.Following firefighter information, the temperature on the boiler surface reached 165°c.According to the pictures provided by the customer, the fuse has popped out so it played its role.Having in mind new information received on 2020-04-30 when the root cause analysis was performed, the complaint is to be reported as the initial risk assessed for this particular case did not take into consideration root cause that is newly established by the subject matter experts at the manufacturer.The risk estimated for the case where installation was incorrect i.E.The machine is connected to faulty power supply is higher than that of a thermal fuse issue ¿ which is how the complaint was first evaluated before the investigation.As a result the issue can lead to serious injury.Therefore, we decided to change the decision regarding the reporting.

• 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: 10100519
• MDR Text Key: 207517928
• Report Number: 9616031-2020-00020
• 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: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9120
• Device Catalogue Number: 9120-002
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/30/2020
• Was Device Evaluated by Manufacturer?: No
• 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