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

Model Number PWD500SFHDK3

Device Problems Break (1069); Detachment Of Device Component (1104)

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

Event Date 12/22/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The stm examined the device and found that the plastic mount holes had broken through.The broken pieces were retained under the screw heads and nothing had fallen off.The stm replaced the camera mount plate with a metal plate and positioned the camera back into place.After verification of safety and functionality, the room was returned to service.The problem was caused by an excessive mechanical stress during manupulation of the camera.

Event Description

While on site for another reason, a maquet service territory manager (stm) was informed that the camera assembly had broken off of the light head in operating room #1 and was hanging by the wires.The incident did not occur during intervention.No patient involvement and no injuries were reported.(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: 5377684
• MDR Text Key: 36739857
• Report Number: 9710055-2016-00005
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• PMA/PMN Number: K070442
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PWD500SFHDK3
• Device Catalogue Number: 568320904
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Initial Date Manufacturer Received: 12/23/2015
• Initial Date FDA Received: 01/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1