MAUDE Adverse Event Report: GETINGE GETINGE 800 SERIES; STERILIZER, STEAM

Model Number 833HC

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 10/13/2017

Event Type  malfunction  

Event Description

For approximately ten days, the door failed to close multiple times after corrections were performed by getinge each time.The could potentially impact patient care.Per reporter, the manufacturer corrected the problem on different occasions.Since the last intervention one week ago, we have not experienced any additional failures.

• Brand Name: GETINGE 800 SERIES
• Type of Device: STERILIZER, STEAM
• Manufacturer (Section D): GETINGE; dennis genito; 45 barbour pond dr; wayne NJ 07470
• MDR Report Key: 6993196
• MDR Text Key: 90793647
• Report Number: 6993196
• Device Sequence Number: 1
• Product Code: FLE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 10/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 833HC
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/30/2017
• Device Age: 4 YR
• Event Location: Hospital
• Date Report to Manufacturer: 10/30/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: N.A.