MAUDE Adverse Event Report: GETTINGE DISINFECTION AB DECOMAT 8666; WASHER DISINFECTOR

Model Number 8666

Device Problem Fire (1245)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/17/2014

Event Type  malfunction  

Event Description

A fire was activated in the hospital by the smoke detectors while the machine was in the dying phase.The machine had caught fire.Emergency services arrived on site and extinguished the fire.As the machine is connected to the lev system it is unknown when exactly the fire started as the smoke was being extracted from the room.

Manufacturer Narrative

Investigation in-process - follow-up report to be submitted.

• Brand Name: DECOMAT 8666
• Type of Device: WASHER DISINFECTOR
• Manufacturer (Section D): GETTINGE DISINFECTION AB; ljungadalsgatan 11; (se-07); 351 15; SW 351 15
• Manufacturer Contact: 1777 e. henrietta rd.; rochester, NY 14623 ; 5852725036
• MDR Report Key: 4279920
• MDR Text Key: 5007671
• Report Number: 9616031-2014-00006
• Device Sequence Number: 1
• Product Code: MEC
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/20/2014

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: 8666
• Initial Date Manufacturer Received: 10/20/2014
• Initial Date FDA Received: 11/19/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1