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

Model Number PRX6401/SAL/DF/T

Device Problem Material Distortion (2977)

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

Event Date 11/03/2016

Event Type  malfunction  

Manufacturer Narrative

The field service technician (fst) evaluated the device and found that paint chips on the spring arm.Maquet assumes that the device failed to meet its specification due to a wrong use (probably collisions with another device or wrong cleaning practices).Maquet has a maintenance contract with this customer and during the last maintenance visit, the fst reported that the spring arm was chipping.Additionally, the device was directly involved with the reported incident however it was not being used to treatment or diagnosis on the patient when the event occurred.In the prismalix series labeling, maquet recommends that the maintenance should be performed by a trained technicians.Per the labeling, the technician should be check the general aspect of the device during annual maintenance.After the last visit in september 2015, the fst sent a quote to the customer in order to replace the spring arm, but the customer never called maquet for a visit.

Event Description

The customer reported that, the spring arm of a surgical light was found with chipping paint in operating roon #8.There were no injuries reported.(b)(4).

• Brand Name: PRISMALIX
• Type of Device: LIGHT, SURGICAL, CEILING MOUNTED
• Manufacturer (Section D): MAQUET SAS; orléans cedex 2 ; FR
• Manufacturer (Section G): FREDERIC LELEU - 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: 6169732
• MDR Text Key: 62674310
• Report Number: 9710055-2016-00101
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K982063
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 11/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PRX6401/SAL/DF/T
• Device Catalogue Number: 567227211.C
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/28/2006
• 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