MAUDE Adverse Event Report: MIZUHO SKYTRON; TABLE, OPERATING-ROOM, AC-POWERED

Model Number 3602

Device Problem Unintended System Motion (1430)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/27/2020

Event Type  malfunction  

Manufacturer Narrative

The skytron authorized representative replaced the pendant control at the facility.The pendant control involved in this case was returned to skytron for evaluation.Skytron was not able to duplicate this failure.The pendant was returned to the manufacturer for evaluation.The manufacturer evaluation found pendant damage from atypical use and force likely that resulted in failure.Skytron will continue to monitor for this failure mode.

Event Description

Facility biomend called skytron technical services department and advised that the table moved in the up direction on its own with a patient on it.The case was finished.No patient injury.Biomed changed hand control that had tears in the rubber cover.Fd ticket number (b)(4).Skytron complaint # (b)(4).

• Brand Name: SKYTRON
• Type of Device: TABLE, OPERATING-ROOM, AC-POWERED
• Manufacturer (Section D): MIZUHO; 3-30-13 hungo, bunkyo-ku; tokyo, 113-0 033; JA 113-0033
• MDR Report Key: 10795000
• MDR Text Key: 215048129
• Report Number: 1825014-2020-00005
• 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: 06/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 3602
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/17/2020
• Distributor Facility Aware Date: 02/27/2020
• Event Location: Hospital
• Date Report to Manufacturer: 02/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1