MAUDE Adverse Event Report: OR BED 90 DEGREES; BED, PATIENT ROTATION, POWERED

Device Problem Unintended System Motion (1430)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/19/2019

Event Type  malfunction  

Event Description

While finishing procedure (right before closing suture was started), the surgical bed unexpectedly and without cause rotated to the left without warning.Personnel scrubbed in at the time were able to catch patient and eased her down to the ground as she slid off without any impact.The waist and legs were still secured to the bed with the safety strap in place, but with the bed almost 90 degrees rotated, the torso slid off the bed.The patient's et tube was still connected.Patient was safely transferred to a new operating room bed and her incision site was cleaned with betadine scrub and paint.Patient was redraped and the procedure was completed.No noticeable physical injury and no known patient harm was sustained.

• Brand Name: OR BED 90 DEGREES
• Type of Device: BED, PATIENT ROTATION, POWERED
• MDR Report Key: 16814450
• MDR Text Key: 314002525
• Report Number: 16814450
• Device Sequence Number: 1
• Product Code: IKZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/19/2023,08/20/2019

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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/19/2023
• Event Location: Hospital
• Date Report to Manufacturer: 04/26/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/26/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 25915 DA
• Patient Sex: Female