MAUDE Adverse Event Report: MAQUET SAS PRISMALIX

Model Number PRX 8000

Device Problems Detachment of Device or Device Component (2907); Torn Material (3024)

Patient Problem No Patient Involvement (2645)

Event Date 12/02/2014

Event Type  malfunction  

Event Description

The customer reported that the light head had come detached from the spring arm but was still hanging on to it by the cables.No injuries were reported to maquet.Factory reference number: (b)(4).

Manufacturer Narrative

The hospital removed the light head from the operating room and put it is quarantine.A maquet technician inspected the lighthead and found that the metallic light head's cover, to which the spring arm is attached to, was warn.The device is no longer in use and will be replaced.This investigation is on-going and the results will be included in a follow-up report.

• Brand Name: PRISMALIX
• Manufacturer (Section D): MAQUET SAS; orleans ; FR
• Manufacturer (Section G): MAQUET SAS; parc de limere; avenue de la pomme de pin; ardon, orleans cedex 2 4507 4; FR 45074
• Manufacturer Contact: marie-francoise cabel ; 37013004
• MDR Report Key: 4379724
• MDR Text Key: 5288811
• Report Number: 9710055-2014-00106
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K040015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 12/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PRX 8000
• Other Device ID Number: 567238998
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/02/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2002
• 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