MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY HARMONY CONNECTPOINT VIDEO CONNECTIVITY SYSTEM; LIGHTING SYSTEM

Device Problems Loose or Intermittent Connection (1371); Device Fell (4014)

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

Event Date 03/19/2019

Event Type  malfunction  

Manufacturer Narrative

The medwatch report did not identify the name or location of the user facility or the serial number of the unit in question.A review of complaints and service requests in this time period found no events which match the received report.The review also confirmed this type of incident to be an isolated occurrence.The harmony connectpoint operator manual (pg 9-1) states: "preventive maintenance schedule: inspect plug buttons, fasteners, covers or other components that may attach to the camera or arm or system arm components." the harmony connectpoint operator manual (pg 9-1) also states: "any repairs or adjustments to harmony connectpoint and its suspension arm should only be made by qualified steris or steris-trained service personnel." a follow-up mdr will be submitted should additional information become available.

Event Description

The user facility reported the screws in the knuckle joint of their harmony connectpoint video connectivity system were falling out.No report of injury; the event did not occur during a patient procedure.Prior to this event, a screw had fallen out during a patient procedure.The facility's biomed department inspected all of their harmony connectpoint units and found they all had similar conditions with loose or missing screws.Reference medwatch report mw5085873.

• Brand Name: HARMONY CONNECTPOINT VIDEO CONNECTIVITY SYSTEM
• Type of Device: LIGHTING SYSTEM
• Manufacturer (Section D): STERIS CORPORATION - MONTGOMERY; 2720 gunter park drive east; montgomery AL 36109
• Manufacturer (Section G): STERIS CORPORATION - MONTGOMERY; 2720 gunter park drive east; montgomery AL 36109
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060 ; 4403927453
• MDR Report Key: 8613625
• MDR Text Key: 145537404
• Report Number: 1043572-2019-00034
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial
• Report Date: 05/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Date Manufacturer Received: 04/17/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1