MAUDE Adverse Event Report: SKYTRON SKYTRON; BEACH CHAIR ACCESORY

Model Number 6500N

Device Problem Disconnection (1171)

Patient Problem Insufficient Information (4580)

Event Date 05/17/2017

Event Type  malfunction  

Event Description

Resubmission of mdr 1825014-2017-00009.Original mdr was submitted incorrectly.This is in response to medwatch (b)(4).While positioning a patient into a beach chair position for right shoulder surgery the shoulder attachment disconnected from the surgical table.No additional details were provided.Skytron has reached out to the initial reporter to obtain further details of the incident.At this time there are no further details to provide.It is not certain at this time if the beach chair accessory device is distributed by skytron.

• Brand Name: SKYTRON
• Type of Device: BEACH CHAIR ACCESORY
• Manufacturer (Section D): SKYTRON; 5085 corporate exchange blvd.; grand rapids MI 49512
• MDR Report Key: 10885061
• MDR Text Key: 217689317
• Report Number: 1825014-2020-00015
• 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: Distributor
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 11/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 6500N
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/20/2020
• Distributor Facility Aware Date: 10/03/2017
• Event Location: Hospital
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other