MAUDE Adverse Event Report: MAQUET SAS POWERLED; LIGHT, SURGICAL, CEILING MOUNTED

Model Number PWD55+DFK3

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Erythema (1840)

Event Date 02/24/2016

Event Type  No Answer Provided  

Manufacturer Narrative

On 04/08/2016 03:00 pm (gmt+2:00) added by (b)(6): the most probable cause is that the skin dried out during exposure to the light, as the redness was observed only on the area that was not covered.The device's labeling contains the following warning: "light is a form of energy that can dry out tissue, particularly if light beams from more than one lighthead are superimposed.Users must be vigilant and set appropriate illumination levels for each operation and patient, in particular for long operations.".

Event Description

On 04/08/2016 02:37 pm (gmt+2:00) added by (b)(6): the customer reported that the skin on the patient's neck, which was not covered with drapes, became red after the operation.A week later, the redness increased.After examination by a dermatologist, it was excluded that the redness was due to the methylene blue administered to the patient during the procedure.(b)(4).

• Brand Name: POWERLED
• Type of Device: LIGHT, SURGICAL, CEILING MOUNTED
• Manufacturer (Section D): MAQUET SAS; orléans cedex 2 ; FR
• Manufacturer (Section G): MARIE-FRANÇOISE CABEL - 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
• MDR Report Key: 5563520
• MDR Text Key: 42386120
• Report Number: 9710055-2016-00026
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K070442
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PWD55+DFK3
• Device Catalogue Number: 568420010C
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/15/2016
• Initial Date FDA Received: 04/08/2016
• 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
• Patient Outcome(s): Other