MAUDE Adverse Event Report: MAQUET SAS LUCEALED; DEVICE, MEDICAL EXAMINATION, AC POWERED

Model Number LUCEA40

Device Problems Component Falling (1105); Crack (1135)

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

Event Date 09/20/2016

Event Type  malfunction  

Manufacturer Narrative

A maquet field service technician evaluated the device and found that the cover was cracked at the location of the fixing screw.Maquet determined that the plastic cover might have cracked due to excessive mechanical efforts on the handle during use.The device does not remain conform to its specification.The device was directly involved with the reported incident and was being used for treatment or diagnosis of the patient when the event occurred.The customer informed maquet that the damaged device is still used, pending repair.

Event Description

The customer reported that the cover of the lighthead was cracked and some particles fell off, during an examination procedure on patient.There were no injuries reported.(b)(4).

Manufacturer Narrative

A maquet field service technician replaced the damaged part and returned the device to service.Per the labelling, users should ¿check the lightheads for chipped paint, impact marks and any other damage¿ on daily basis.

Event Description

(b)(4).

• Brand Name: LUCEALED
• Type of Device: DEVICE, MEDICAL EXAMINATION, AC POWERED
• Manufacturer (Section D): MAQUET SAS; orléans cedex 2 ; FR
• Manufacturer (Section G): MAQUET SAS; parc de limère; avenue de la pomme de pi; orléans cedex 2 45074 ; FR 45074
• Manufacturer Contact: parc de limère; avenue de la pomme de pi; orléans cedex 2 45074 ; 0332382587
• MDR Report Key: 6029664
• MDR Text Key: 57717292
• Report Number: 9710055-2016-00091
• Device Sequence Number: 1
• Product Code: KZF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 11/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LUCEA40
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Date Manufacturer Received: 09/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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