MAUDE Adverse Event Report: WALDMANN LIGHTING HALAX 50; LIGHT, EXAMINATION

Model Number 6600-0887-702

Device Problem Device Disinfection Or Sterilization Issue (2909)

Patient Problem No Information (3190)

Event Date 05/19/2014

Event Type  No Answer Provided  

Event Description

Tearing and exposed core on the exam light sleeves have many factors, such as infection control issues because the area cannot be cleaned or disinfected.

• Brand Name: HALAX 50
• Type of Device: LIGHT, EXAMINATION
• Manufacturer (Section D): WALDMANN LIGHTING; 9 west century drive; wheeling , IL 60090
• MDR Report Key: 4426418
• MDR Text Key: 5167914
• Report Number: 4426418
• Device Sequence Number: 1
• Product Code: KZF
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 12/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: *
• Device Operator: Invalid Data
• Device Model Number: 6600-0887-702
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/17/2014
• Event Location: Hospital
• Date Report to Manufacturer: 01/16/2015
• Patient Sequence Number: 1