MAUDE Adverse Event Report: ADVANCED STERILIZATION PRODUCTS SERVICES INC. STERRAD STERILIZER; STERILIZER, CHEMICAL

Device Problem Pressure Problem (3012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/24/2022

Event Type  malfunction  

Event Description

Biomed was alerted that a sterrad sterilizer in the sterile processing department failed a load and gave an error message of "pressure check fail".The manufacturer was called, and a service engineer was dispatched to the hospital.The machine was down for a significant amount of time, and delayed the processing of medical equipment in these sterilizers.

• Brand Name: STERRAD STERILIZER
• Type of Device: STERILIZER, CHEMICAL
• Manufacturer (Section D): ADVANCED STERILIZATION PRODUCTS SERVICES INC.; 33 technology drive; irvine CA 92618
• MDR Report Key: 15592637
• MDR Text Key: 301736363
• Report Number: 15592637
• Device Sequence Number: 1
• Product Code: MLR
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/21/2022,09/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2022
• 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?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/21/2022
• Device Age: 3 YR
• Event Location: Hospital
• Date Report to Manufacturer: 10/12/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1