MAUDE Adverse Event Report: STERIS CORPORATION; LIGHT, SURGICAL, CEILING MOUNTED

Device Problems Overheating of Device (1437); Detachment of Device or Device Component (2907); Device Fell (4014)

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

Event Date 12/29/2019

Event Type  malfunction  

Event Description

After a cath procedure, patient's mother lifted baby off bed and back of adjustable overhead procedure light fell off onto the bed where the baby had been seconds before.Steris overhead light.The back of the light was removed from service, but unable to remove entire adjustable light.Per biomed, loose tension screw on plastic cover.Tightened screw and verified the cover was secure.

• Type of Device: LIGHT, SURGICAL, CEILING MOUNTED
• Manufacturer (Section D): STERIS CORPORATION; 2720 gunter park drive east; montgomery AL 36109
• MDR Report Key: 9610650
• MDR Text Key: 175678440
• Report Number: 9610650
• Device Sequence Number: 1
• Product Code: FSY
• 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: 01/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/09/2020
• Event Location: Hospital
• Date Report to Manufacturer: 01/21/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1