MAUDE Adverse Event Report: GETINGE DISINFECTION AB STERILIZATION WASHER; DISINFECTOR, MEDICAL DEVICES

Device Problems Break (1069); Positioning Problem (3009)

Patient Problem Insufficient Information (4580)

Event Date 05/25/2022

Event Type  malfunction  

Event Description

When clinical engineering arrived to csr, both windows on the washer were open, however, the clean side was only open by 3 inches.Biomed rep proceeded to call getinge local vendor in hopes that the issue could be resolved over the phone and was able to close both doors, but the unit was still not fully functional.The next day when field service tech from getinge arrived, he discovered the harness wire was out of position and may have cause the issue but was not really sure it was damaged due to trying to get the door open to verify.He also tested the door switches, which all passed according to the tech.Once the harness was re-adjusted, the unit passed all door test and was placed back into service.

• Brand Name: STERILIZATION WASHER
• Type of Device: DISINFECTOR, MEDICAL DEVICES
• Manufacturer (Section D): GETINGE DISINFECTION AB; 45 barbour pond dr; wayne NJ 07470
• MDR Report Key: 15073403
• MDR Text Key: 296304389
• Report Number: 15073403
• Device Sequence Number: 1
• Product Code: MEC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/15/2022
• Event Location: Hospital
• Date Report to Manufacturer: 07/21/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1