MAUDE Adverse Event Report: STRYKER COMMUNICATION BERCHTOLD SURGICAL TABLE; TABLE, OPERATING-ROOM, ELECTRICAL

Model Number OPERON D 860

Device Problems Component Falling (1105); Unintended System Motion (1430); Power Conditioning Problem (1474)

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

Event Date 01/25/2018

Event Type  malfunction  

Event Description

At the end of the breast reconstruction surgery, staff were gently turning the pt to apply post surgical bra and abdominal binder.While turning, the bed controller slipped off the bed and fell to the floor.The head of the bed immediately started to raise up to 60-90 degrees.The staff attempted to use the bed controller to lower head of bed, but it appeared to not have power (power light was off).The control panel (at the base of the bed) had a controller there, however, it did not work.The main power to the bed was switched off/on and then the back down button on the controller was pressed.The bed stopped.There was no injury to the pt.

• Brand Name: BERCHTOLD SURGICAL TABLE
• Type of Device: TABLE, OPERATING-ROOM, ELECTRICAL
• Manufacturer (Section D): STRYKER COMMUNICATION; flower mound TX
• MDR Report Key: 7233727
• MDR Text Key: 98869313
• Report Number: MW5075003
• Device Sequence Number: 1
• Product Code: GDC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: OPERON D 860
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 63