MAUDE Adverse Event Report: STERIS AMSCO/STERIS OPERATING ROOM BED; GENERAL SURGICAL TABLE

Model Number BL57727-330

Device Problems Failure to Charge (1085); Battery Problem (2885)

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

Event Date 04/03/2018

Event Type  malfunction  

Event Description

In middle of case, bed started moving while patient was docked to robot.It was discovered that the battery for the bed had run down to empty even though it was plugged into a power strip.Bed gave no warning that battery was running down or depleted.No injuries to patient.Bed removed from service for inspection.Manufacturer: please note that we do not send products to the manufacturer, but you may arrange for pick-up by sending an e-mail to the address below.

• Brand Name: AMSCO/STERIS OPERATING ROOM BED
• Type of Device: GENERAL SURGICAL TABLE
• Manufacturer (Section D): STERIS; 5960 heisley rd. ; mentor OH 44060
• MDR Report Key: 7424949
• MDR Text Key: 105452119
• Report Number: MW5076445
• Device Sequence Number: 1
• Product Code: FQO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BL57727-330
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/11/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 67 YR