MAUDE Adverse Event Report: STERIS CORPORATION STERIS 4085; TABLE, OPERATING-ROOM, AC-POWERED

Model Number 4085

Device Problems Material Twisted/Bent (2981); Noise, Audible (3273)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/21/2019

Event Type  malfunction  

Event Description

While positioning the bed in procedure for the patient in the operating room, the team noticed the metal shroud on the bed was bent.Did not affect the operation of the bed, but as a precaution since the patient was under anesthesia, the bed was swapped for another bed.After the patient was under general anesthesia, the surgical team was in the process of positioning the patient for the planned procedure.While elevating the operating room bed to the surgeon's requested height, a noise was noted as coming from the column of the bed.Upon investigating it was found that part of the metal housing that makes up the shroud was bent.The decision was made at that point to pause the procedure and transfer the patient to another bed.The transfer was completed without complications.At this point the bed in question was removed and the procedure was resumed.The bed was then sent to biomed for evaluation.The procedure was completed without harm to the patient.Staff shared that the bent area may have been from placing objects under bed such as scd machines etc.

• Brand Name: STERIS 4085
• Type of Device: TABLE, OPERATING-ROOM, AC-POWERED
• Manufacturer (Section D): STERIS CORPORATION; 2720 gunter park drive east; montgomery AL 36109
• MDR Report Key: 9139438
• MDR Text Key: 160709020
• Report Number: 9139438
• Device Sequence Number: 1
• Product Code: FQO
• 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: 09/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 4085
• 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: 09/20/2019
• Event Location: Hospital
• Date Report to Manufacturer: 10/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 12410 DA