MAUDE Adverse Event Report:; OPERATING ROOM ACCESSORIES TABLE TRAY

Device Problems Bent (1059); Device Dislodged or Dislocated (2923)

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

Event Date 04/27/2018

Event Type  malfunction  

Event Description

The patient was transferred to an operating room (or) table with the beachchair positioner for a shoulder scope procedure in the operating room (or).The patient's body weight began to make the beachchair lower on its own.The beachchair was stabilized by the dr.The patient was asked to move back over onto the cart so we could investigate the beachchair.The left post on the positioner was noted to be bent within the bracket clasp.The right post had become dislodged from the bracket clasp and was no longer attached to the operating room (or) bed.The beachchair positioner was removed from the operating room (or) bed and another beachchair positioner was brought in and placed on the operating room (or) table.It was inspected by the dr prior to asking the patient to transfer over from the cart again.

• Type of Device: OPERATING ROOM ACCESSORIES TABLE TRAY
• MDR Report Key: 7581510
• MDR Text Key: 110452176
• Report Number: 7581510
• Device Sequence Number: 1
• Product Code: FWZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Unknown
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/08/2018
• Event Location: Hospital
• Date Report to Manufacturer: 05/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO OTHER THERAPIES
• Patient Age: 41 YR
• Patient Weight: 124