MAUDE Adverse Event Report: MIDMARK CORP. MIDMARK; SURGICAL LIGHT

Model Number 529-060-00

Device Problem Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/04/2015

Event Type  No Answer Provided  

Event Description

The clinician user grabbed the handle to move the light when the bulb cracked.A piece of the bulb landed on the clinician's gown.No medical attention required.

Manufacturer Narrative

Voltage testing performed as expected.No performance issues were identified.The unit was not returned to midmark for assessment.This product is no longer manufactured by midmark.There is no history of similar event.Unable to confirm cause of the failure.

• Brand Name: MIDMARK
• Type of Device: SURGICAL LIGHT
• Manufacturer (Section D): MIDMARK CORP.; versailles OH
• Manufacturer Contact: jane carrol ; 60 vista dr.; versailles, OH 45380 ; 9375268604
• MDR Report Key: 4828022
• MDR Text Key: 21340016
• Report Number: 1523530-2015-00004
• Device Sequence Number: 1
• Product Code: EAZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 529-060-00
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/04/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/1997
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1