MAUDE Adverse Event Report: SKYTRON LLC SKYTRON TILT BED; SURGICAL TABLE

Model Number 6100-1

Device Problems Unstable (1667); Improper or Incorrect Procedure or Method (2017)

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

Event Date 09/20/2019

Event Type  malfunction  

Event Description

Investigation summary: the night shift hospital assistant set up operating room bed 6001-01.Circulating rn completed a morning room check which includes the complete check of the operating room 6001-01 bed.The circulating rn completed the bed check of the 6001-01, including: bed locked, all bed components/pieces locked.The circulating rn did not complete the final bed check of correct orientation of all components/pieces.The circulating rn and scrub rn were unaware of the instability of the 6001-01 bed due to the incorrect orientation and configuration of the bed pieces.This was not a bed malfunction.Cause: the omission of the routine check and double check of the 6001-01 bed orientation and configuration of the bed pieces by the hospital assistant and the circulating rn.Actions: educate/re-educate staff (hospital assistants and nurses) on the best practice for routine checks of all operating room beds prior to the start of all surgical procedure.

• Brand Name: SKYTRON TILT BED
• Type of Device: SURGICAL TABLE
• Manufacturer (Section D): SKYTRON LLC; 5085 corporate exchange blvd se; grand rapids MI 49512
• MDR Report Key: 9327541
• MDR Text Key: 166539913
• Report Number: 9327541
• 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: 10/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 6100-1
• 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: 10/31/2019
• Event Location: Hospital
• Date Report to Manufacturer: 11/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 17885 DA